609 Mdr Jobs - Page 9

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements. Capable of mentoring junior quality engineers in providing quality engineering support. Responsibilities may include the following and other duties may be assigned Review New Product Introduction (NPI) and Released Product Management (Released Products) documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements. Hands on experience with tools package release process for both Software & Hardware tools/accessories Review non product/off-the shelf tools for products Experience in software or hardware design transfer process for tools or products Familiar with ISO 13485, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Ensure that product development projects and changes to existing products are conducted in compliance with IEC 62304, FDA Quality System Regulations, EU MDR and inhouse Standards. Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report). Assist in the creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance. Hanson experience in SW anomaly evaluation and disposition, complaint investigation, NC/CAPA Ensure successful transfer of new products/tools to production facility by assisting in development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques. Review Design History Files and Technical Files for conformance to applicable requirements. Participate when appropriate in audits Ensures applicability to SOUP / OTS validations in the product development Participate and provide input to training on department / procedures and policies Hands-on experience on Software Risk Management, Design Controls. Develop templates and training based on the quality system regulations, applicable standards and guidance. Independently reviews all SW deliverables to ensure compliance with development process and the standard. Deliver presentations to the QA organization on status and issues of assigned projects. Deliver training to departments outside of QA. Previous experience working in a cross-functional team environment. Provide Quality support to facilitate resolution of product complaints and/or safety issues Provide support to the Regulatory Department in writing technical submissions. Required Knowledge And Experience B E or B.Tech Minimum 6-8 years of quality engineering experience or equivalence and overall 8-12 years of experience Previous experience working in a cross-functional team environment. Familiar with statistical software tools (Minitab, Stat Graphics) Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive. Strong in software design and development, software verification and validation activities Computer literate and experience with PCs, networks, applications, software development life cycle Travel may be required Knowledge in cybersecurity Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here

About Paytm Group: Paytm is India's leading mobile payments and financial services distribution company. Pioneer of the mobile QR payments revolution in India, Paytm builds technologies that help small businesses with payments and commerce. Paytm’s mission is to serve half a billion Indians and bring them to the mainstream economy with the help of technology. About the Role As a Product Manager for Card Acquiring , you will be responsible for building and scaling card-based payment products for our vast network of offline and online merchants. You will work closely with banks, networks (Visa, Mastercard, Rupay, American Express), and internal teams to deliver high-performance card processing solutions. You will be the voice of the merchant and the architect of high-SR, low-latency, and regulation-compliant card payment infrastructure. Ke y Responsibilities:- Own the end-to-end lifecycle of card acquiring products – from strategy and roadmap to execution and post-launch performance. Define product features and enhancements focused on card payment acceptance across POS, online, and in-app channels. Integrate and manage partnerships with issuer and acquirer banks, card networks, and processors. Monitor and drive improvements in key metrics such as transaction success rate (SR), latency, authorization rates, fraud, and chargebacks. Lead initiatives related to card tokenization, contactless/NFC enablement, recurring payments (SI on cards), and international acceptance. Collaborate with engineering, design, risk, legal, and compliance to ensure scalable and compliant rollout of features. Track RBI regulations, network advisories, and ensure product readiness and compliance. Work with sales and operations teams to enable adoption and resolution of merchant issues. What You’ll Need 4–8 years of product management experience, with at least 2 years in card payments, acquiring, or processing. Strong understanding of card acquiring infrastructure, transaction lifecycle, settlement, MDR, and risk/fraud handling. Experience in working with card networks (Visa, Mastercard, Rupay), acquiring banks, or payment processors. Data-driven decision-making with hands-on experience in SQL, Excel, or dashboarding tools. Excellent stakeholder management, cross-functional collaboration, and problem-solving skills. Familiarity with RBI and PCI-DSS compliance standards is a plus. Why Join Us Be a key player in shaping the card payments experience for millions of Indian merchants. Solve for scale: Handle transaction volumes at one of the largest payment processors in India. Work with some of the most talented teams across product, engineering, and design. Join a fast-paced, impact-driven environment with a focus on innovation, ownership, and excellence. Compensation : If you are the right fit, we believe in creating wealth for you With enviable 500 mn+ registered users, 17 mn+ merchants and depth of data in our ecosystem, we are in a unique position to democratize credit for deserving consumers & merchants – and we are committed to it. India’s largest digital lending story is brewing here. It’s your opportunity to be a part of the story!

At Scybers, we’re seeking a sharp, vigilant, and dynamic Detection & Response Lead to join our Managed Detection and Response (MDR) team. Step into a pivotal role where every day brings new challenges, and your strategic decisions will have a significant impact on our clients’ security. Preference will be given to candidates who can join immediately or short notice. What you will do, Handle client engagements and work as the main point of contact for MDR projects Continuously improve client engagement and the quality of delivery to SOC customers. Implement standards and procedures for projects to ensure alerts are addressed with relevancy, accuracy and in a timely manner Define process and maturing of 'playbooks' for operational response to cyber threats Operate autonomously to further investigate and escalate in accordance with policies, procedures and defined processes Mentoring and guiding the SOC analysts Lead SOC analysts during incident response actions, advise and coordinate with leadership during active incidents Identify and develop SOC related metrics via dashboard and/or reports for client engagements What we look for, 4+ years experience in SOC or similar capacity (Having experience in MSSP environments will be advantageous) A degree in Computer Science, IT or a Cyber-Security related field. One or more cybersecurity related certification (CySA+, CEH, CSA, ECIH, Cloud & etc). Ability to work and collaborate in a team and lead projects and engagements effectively utilizing resources. Experience in handling SOC daily operations and process / procedure management Strong skills in incident response and technical documentation Experience leading high performing technical teams Strong communication skills is essential Strong leadership qualities and the ability to motivate Experience in engaging in cloud security incidents and SIEM Engineering will be an added advantage. Continuously developing investigative and cybersecurity skills through research and training.

Job Purpose: To ensure effective and timely management of product complaints by receiving, documenting, investigating, analyzing, and resolving product-related complaints in compliance with applicable regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820, MDR). The role supports continuous improvement of product quality and customer satisfaction. Key Responsibilities: Receive and log product complaints from customers, sales team, or regulatory bodies in the complaint management system. Acknowledge receipt of complaints and communicate resolution timelines to complainants. Evaluate the complaint to determine if it qualifies as a reportable event per regulatory requirements. Coordinate with cross-functional teams (R&D, Quality, Manufacturing, etc.) to investigate root cause(s). Ensure timely and accurate completion of complaint investigations, CAPA initiation (if required), and closure within defined timelines. Document complaint details, investigation findings, corrective actions, and outcomes. Communicate findings and resolutions to stakeholders and customers. Generate monthly/quarterly complaint trend reports and risk assessments. Support external/internal audits and regulatory inspections by providing complaint-related documentation. Maintain compliance with company SOPs, ISO standards, and regulatory requirements. Recommend preventive actions and contribute to quality improvement initiatives. Required Qualifications and Skills: Bachelor’s degree in Pharmacy, Science, Biomedical Engineering, or equivalent field. 3+ years of experience in product complaint handling, preferably in the medical device or pharmaceutical industry. Knowledge of ISO 13485, FDA regulations, MDR, and other global regulatory requirements. Strong analytical, problem-solving, and documentation skills. Familiarity with complaint management software or QMS tools (e.g., TrackWise, MasterControl, etc.). Excellent communication skills – written and verbal. Attention to detail and a commitment to quality and compliance. Preferred Qualifications: Certification in Quality Management Systems or Regulatory Affairs. Experience in root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA). Exposure to CAPA, NC, and audit handling processes.

About Us Sophos is a global leader and innovator of advanced security solutions for defeating cyberattacks. The company acquired Secureworks in February 2025, bringing together two pioneers that have redefined the cybersecurity industry with their innovative, native AI-optimized services, technologies and products. Sophos is now the largest pure-play Managed Detection and Response (MDR) provider, supporting more than 28,000 organizations. In addition to MDR and other services, Sophos’ complete portfolio includes industry-leading endpoint, network, email, and cloud security that interoperate and adapt to defend through the Sophos Central platform. Secureworks provides the innovative, market-leading Taegis XDR/MDR, identity threat detection and response (ITDR), next-gen SIEM capabilities, managed risk, and a comprehensive set of advisory services. Sophos sells all these solutions through reseller partners, Managed Service Providers (MSPs) and Managed Security Service Providers (MSSPs) worldwide, defending more than 600,000 organizations worldwide from phishing, ransomware, data theft, other every day and state-sponsored cybercrimes. The solutions are powered by historical and real-time threat intelligence from Sophos X-Ops and the newly added Counter Threat Unit (CTU). Sophos is headquartered in Oxford, U.K. More information is available at www.sophos.com. Role Summary As a Senior Engineer, you will play a key role in the design, development, and delivery of embedded software solutions for cutting-edge wireless access points. You will work with a team of firmware developers while driving the technical strategy and ensuring the successful integration of firmware with hardware components. This position requires a deep understanding of wireless technologies, advanced problem-solving skills, and a strong commitment to innovation and quality. These wireless access points are managed from cloud as well and this role gives immense opportunity to work on cloud technologies as well. What you will do Collaborate with cross-functional teams, including hardware, software, and product management, to define product requirements and develop long-term technology strategies Partake resolution of complex technical challenges, including low-level debugging, performance optimization, and integration with advanced hardware components Drive the implementation and optimization of wireless networking protocols (e.g., 802.11 standards) and ensure robust security features, including encryption, authentication, and secure boot processes Identify and implement opportunities for innovation in firmware design, focusing on performance improvements, power efficiency, and scalability of wireless access point solutions Oversee the development and execution of rigorous testing and validation processes to ensure the highest levels of firmware quality and reliability Liaise between the firmware team and other stakeholders, effectively communicating complex technical concepts to non-technical audiences What you will bring 7 – 11 years of total working experience Extensive experience in embedded C/C++/Go programming and firmware development for wireless networking devices 2+ years of work experience in the relevant domain and discipline Deep understanding of wireless networking protocols, particularly 802.11 standards Expertise in real-time operating systems (RTOS) and embedded Linux environments Strong knowledge of hardware-software co-design, low-level debugging, and performance optimization Experience with security features and best practices in embedded systems Strong problem-solving skills. Should have experience with the integration of REST APIs Good to have knowledge of authentication and authorization frameworks Ability to work both independently and in a team environment Demonstrate passion, desire, and dedication to ongoing learning Proactive, flexible attitude towards work with a willingness to constantly review and improve skills and processes Bachelor of Science in Computer Software, Computer Science, or related discipline or equivalent experience #B2 Ready to Join Us? At Sophos, we believe in the power of diverse perspectives to fuel innovation. Research shows that candidates sometimes hesitate to apply if they don't check every box in a job description. We challenge that notion. Your unique experiences and skills might be exactly what we need to enhance our team. Don't let a checklist hold you back – we encourage you to apply. What's Great About Sophos? · Sophos operates a remote-first working model, making remote work the primary option for most employees. However, some roles may necessitate a hybrid approach. Please refer to the location details in our job postings for further information. · Our people – we innovate and create, all of which are accompanied by a great sense of fun and team spirit · Employee-led diversity and inclusion networks that build community and provide education and advocacy · Annual charity and fundraising initiatives and volunteer days for employees to support local communities · Global employee sustainability initiatives to reduce our environmental footprint · Global fitness and trivia competitions to keep our bodies and minds sharp · Global wellbeing days for employees to relax and recharge · Monthly wellbeing webinars and training to support employee health and wellbeing Our Commitment To You We’re proud of the diverse and inclusive environment we have at Sophos, and we’re committed to ensuring equality of opportunity. We believe that diversity, combined with excellence, builds a better Sophos, so we encourage applicants who can contribute to the diversity of our team. All applicants will be treated in a fair and equal manner and in accordance with the law regardless of gender, sex, gender reassignment, marital status, race, religion or belief, color, age, military veteran status, disability, pregnancy, maternity or sexual orientation. We want to give you every opportunity to show us your best self, so if there are any adjustments we could make to the recruitment and selection process to support you, please let us know. Data Protection If you choose to explore an opportunity, and subsequently share your CV or other personal details with Sophos, these details will be held by Sophos for 12 months in accordance with our Privacy Policy and used by our recruitment team to contact you regarding this or other relevant opportunities at Sophos. If you would like Sophos to delete or update your details at any time, please follow the steps set out in the Privacy Policy describing your individual rights. For more information on Sophos’ data protection practices, please consult our Privacy Policy Cybersecurity as a Service Delivered | Sophos

Purpose of the Role The Senior Salesforce Administrator is responsible for supporting the overall maintenance of the Salesforce platform. Acting as a central point of orchestration for developers, support teams, as well as end users, the administrator provides critical day to day support for deployment, user setup, data, monitoring, troubleshooting, enhancing, automating, reporting, upgrading and training of the platform. The Admin will also act as a first level SME for the Complaint Handling Process within the Trackwise system Primary Duties and Responsibilities Own the end to end administration of the Salesforce Platform including user management, workflows, and basic validations. Deployment of platform changes, by collaborating with the global platform, application development & support teams Provide expert support with setup and maintenance of reports and dashboards Plan and manage release & upgrade of environments covering Salesforce Seasonal Releases, Trackwise Releases & Regular Change Requests Perform data load activities on demand Support MDR & other Regulatory/Compliance related activities Collaborate with offshore support teams to manage incidents , change requests & integrations Supervision of incidents , change requests & integrations collaborating with the external vendor teams Competencies Development Support: Support new developer onboarding activities Release Execution: Responsible to execute releases from SF, Trackwise & Olympus changes. Issue Resolution: Troubleshoot and resolve complex technical issues in collaboration with development teams and vendor support. Support Key Users and manage their delegated administration Administration of DevOps Infrastructure, Sandbox Management (clone, refresh, etc) & related access Security Review: Support regular security review activities by extracting the relevant reports and working with the Application owner Minimum Qualification Education*: Bachelor’s Degree in IT or Engineering or Computer Applications Experience*: Certified in Salesforce Administration 3+ years in Salesforce Administration & DevOps activities 2+ years with Trackwise or a similar Quality Management System. Skills: Good knowledge of Salesforce architecture and related technologies Good knowledge on SF development best practices, objects Experience with Agile/Scrum Techniques and tools like JIRA. Strong communication (verbal/written/listening) skills. Good organizational skills with an eye for detail and able to work within a team setting. Experience working with and/or driving remote teams across continents and time zones is a huge benefit.

University degree level or equivalent through experience and professional certification. A minimum of 4-7 years in Security and Loss prevention role, law enforcement or security-related profession. Extensive and up to date knowledge of Shrink management and Data Analysis. Experience in managing or coordinating security investigations of complex nature. Knowledge of information security processes and systems. Experience in security auditing Amazon’s SLP team is seeking highly skilled and motivated person to help develop a and implement a world class security program for our first mile network which will ensure that our customers receive the items they purchase on time and at the best possible cost. Amazon is one of the most recognizable brand names in the world and we distribute millions of products each year to our loyal customers. The SLP Specialist – MDR Return, will be responsible for partnering with respective stakeholders and prog teams spread across various cities within a region to execute company security policies and provide security services and asset (lives, inventory in transit and within sort center, buildings, equipment, data, & intellectual property) protection within the assigned location and the surrounding geography. The Manager is a key member of the AMZL working with the Regional team as well as cross functional teams throughout the organization. · Perform risk assessment of site & operation model and frame mitigation measures Possess a thorough understanding of central/state security issues and demonstrate excellence in ability to implement and ensure sites compliance with company security policies and any industry or merchant requirements. Completing and/or coordinating the final Test and Acceptance of site security systems that leverage our access control system. Establish and implement effective, predictable, measurable procedures/processes and prevention programs impacting losses, pilferage, accident trends and conduct job hazard and job safety analyses Perform frequent site security audits to identify all non-compliance equipment and/or processes at the site. Implement solutions to eliminate exposure to these risks and prevent injury. Ensure guarding vendor(s) have clear understanding of expectations and hold them accountable to deliver on them and meet or surpass service level agreement requirements. In addition, work with the guarding vendor’s management to ensure that they recruit, hire, and retain candidates who raise the performance bar of the security services organization Builds and deploys security training program Serve as department’s liaison and security subject matter expert Effectively address safety and security incidents including potential and actual work place violence incidents per policy as well as conducting testing of the incident response plans. Enhance, track, and report on metrics which are key performance indicators Coordinate with various support teams such as the Worldwide Operations Security Team, IT Security, and Network Engineering as needed Utilize Kaizen, Lean and Six Sigma methods to drive process improvements and increase efficiency. Loss Prevention, Investigation/Security related Certifications. Preferably from Military/Law enforcement or Studies related to criminology or forensics background. Emergency Response / Crisis Management & Training & Development. Auditing and security investigations Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you’re applying in isn’t listed, please contact your Recruiting Partner. Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you’re applying in isn’t listed, please contact your Recruiting Partner.

We are hiring stores executive , You will be assisting in daily management of overall material stores. Inward materials quantity checking & packing machine & other Items. Also Labelling the GRN Stickers Walk IN Below Address 07th Jul-25 to 9th Jul-25 Address Prognosys Medical System Pvt Ltd Survey No. 168/1, Machohalli, Dasanapura Hobli, Next to Vani Vidyalaya, Off Magadi Road, Bengaluru, Karnataka, 560091 Visit Us: https://prognosysmedical.com/ Or reach us Mobile : 8951092392 Email : hr@prognosysmedical.com JD · Preparation of GRN as per the requirements · Handling all job work items & send via DC to vendors · Handling stock items of C-ARM / MDR /Service · Monitoring and control of Issues & receiving materials · Stocking related items/materials in its Locations passed by QC · Maintaining BOM items and issues to Production · Issuing BOM items/materials & updating them in Tally · Monitoring and control of Dispatch materials & Document · Preparing E-way bills and insurance documents · Handling service items, preparing, monitoring DC & also follow-up (Couriers) · Assisting in packing of all machines’, logistics, porter, payments related activities · Manage & oversee store operations Authorized signatory of GRN & DC Education: Any Graduate Good Knowledge in computer system Tally certification or experience would be plus Job Types: Full-time, Permanent, Fresher Pay: ₹15,000.00 - ₹20,000.00 per month Benefits: Food provided Health insurance Provident Fund Schedule: Day shift Fixed shift Education: Bachelor's (Required) Location: Bengaluru, Karnataka (Preferred) Work Location: In person Speak with the employer +91 8951092392 Application Deadline: 09/07/2025 Expected Start Date: 09/07/2025

Job Description Job Overview: The Principal Structural Engineer is responsible for interpreting internal or external business issues and recommending best practices. They will be tasked with solving complex structural-related problems and will work independently with minimal guidance. The Principal Structural Engineer may be responsible for leading functional teams or projects and is regarded as a specialist in the field of structural engineering. As such, they must have in-depth expertise in structural engineering as well as broad knowledge of the structural discipline within the engineering function. Responsibilities Key Tasks and Responsibilities: Perform conceptual, FEED, and detailed analyses and design as per design basis, project specifications, design codes, and standards Apply in-depth skills and broad knowledge of the business to address complex problems and nonstandard situations Prepare clear and accurate detailed design calculations and analyses including design reports and - procedures Manage own time to meet objectives and (as Lead Engineer) forecast and plan resource requirements Clearly communicate and explain difficult concepts and persuade others to adopt a point of view When acting as Lead Engineer, in addition: Direct medium or large Engineering team as a Lead Engineer Lead the Discipline engineering design of the assigned work area and complete it within the planned schedule and budget, in accordance with standards, MDR, and project-specific procedures and to a high professional standard Plan, organize, and direct all aspects of Discipline execution on the assigned project including scope, deliverables, schedule, and all manpower resources - agree allocations with the Discipline Manager Ensure interfaces and deliverables are clearly identified Maintain responsibility for progress and productivity, identifying any required corrective action Act as project representative for the Discipline during meetings with Project Team, Customer discipline lead and relevant agencies such as certifying authorities, auditors, third parties, etc. Train/mentor other employees in the department Assist and monitor MOPEX offices on projects Has a good understanding of the other engineering departments Initiate interface with other disciplines to obtain input for discipline designs Has a good understanding of construction/fabrication yard and client requirements Has commercial insight Helps to maintain unifi Prepare bid from sketching data, using experience Supervise engineers and designers Define scopes of work for engineering/construction fabrication yard Provide engineering support as required Perform engineering checks of drafting Perform engineering checks prepared by others within the discipline Perform design verification through single discipline check and assist with inter-discipline checks (IDC) Prepare MTOs of structures Prepare specifications Prepare subcontract Review of vendor data Prepare technical bid evaluations Assist in furthering the department Tasks as Lead Engineer: Work as Lead Engineer on medium to large-size EPC projects Responsible for all engineering and design work on any project Has full control and manages work hours, materials, progress Work in close liaison with the Design Coordinator Set up all engineering computer systems Assist Project Manager in: Preparing deliverable control Preparing schedule Preparing progress reports Preparing man-hour and capital expenditure estimates Coordinate with project management Train personnel under their supervision Is responsible for discipline within the engineering group Manage (design) subcontracts Identify and manage changes in the scope of work Is responsible for filing of engineering work Give relevant feedback to the department Reports to: Project: Project: Project Engineering Manager, or Project Manager Functional: Supervising Department Manager Liaise with: All Engineering disciplines, Construction site/Fabrication Group, Safety Dept, Project Management Team, Document Control, Project Planner, Project Cost Controller, QC and Certification Group, Procurement Group, Subcontractors and Vendors, and Customers Supervises: Senior Engineers, Engineers and Designers Qualifications Essential Qualifications and Education: Bachelor's Degree or Master's Degree in engineering 15-20 years of experience in oil and gas with a major contractor or consultants predominantly performing detail design Preferably Registered Professional Engineer or member of professional engineering society as applicable Seasoned structural knowledge Very good organizer, motivator, and supervisor Able to solve problems without assistance Keen on improving the effectiveness of the work HSE, TQM and cost-conscious Fluent in English, both oral and written Understanding and supporting company goals and work processes Show flexibility and ensure proper hand-over with regards to: The reassignment to other departments/construction sites/fabrication yards The reassignment to other McDermott offices The replacement of colleagues during illness and holidays The provision of assistance to other colleagues with heavy workloads (also other projects) when possible/desirable The managing/learning of future current working methods and software applications Detailed knowledge of design techniques and analysis methods, and detailed knowledge of the theory, content, and application of standards, codes, and guidelines as applicable Knowledgeable in project coordination and execution skills About Us Our ingenuity fuels daily life. Together, we’ve forged some of the most trusted partnerships across the energy value chain to make what was once just an idea a reality: laying subsea infrastructure thousands of feet below sea level, installing platforms hundreds of miles from shore, using our expertise to design and build offshore wind infrastructure, and reshaping the onshore landscape to deliver the energy products the world needs safely and sustainably. For more than 100 years, we've been making the impossible possible. Today, we're driving the energy transition with more than 30,000 of the brightest minds across 54 countries.

Close date: Sunday, 17 August 2025 Working pattern: Full time Contract Type: Permanent Location: Gurgaon (SEZ1) Department: 13 - 13 Security Description & Requirements: Bravura’s Commitment and Mission At Bravura Solutions, collaboration, diversity and excellence matter. We value your ideas, giving you room to be curious and innovate in an exciting, fast-paced, and flexible environment. We look for many different skills and abilities, as well as how you can add value to Bravura and our culture. As a Global FinTech market leader and ASX listed company, Bravura is a trusted partner to over 350 leading financial services clients, delivering wealth management technology and products. We invest significantly in our technology hubs and innovation labs, which inspire and drive our creative, future-focused mindset. We take pride in developing cutting-edge, digital first technology solutions that support our clients to achieve financial security and prosperity for their customers. About The Role Bravura is a fast-moving finance technology company and managed service provider, supporting large financial services institutions across multiple jurisdictions. As a trusted data processor for our clients, security is at the core of what we do. Our business is evolving rapidly, and this is a unique role to help shape a growing information security function during a period of high-impact transformation. The Security Operations Analyst will support build out of our internal capability and partner closely with our outsourced SOC provider. This is a hybrid role combining incident response coordination, vulnerability management, and offensive security activities—including penetration testing support and remediation tracking. You’ll play a vital role in ensuring we meet both our internal security obligations and the high expectations of our financial services clients. What You’ll Do Act as the in-house lead for escalations from our third-party MDR/SOC, supporting triage, investigation, and coordination of incident response Support the vulnerability management programme such as scan scheduling, triage, risk prioritisation, and remediation tracking Coordinate internal and third-party penetration tests, supporting remediation efforts and reporting Ensure security operations support our obligations as a data processor and align with clients’ requirements Track and report on operational metrics and security KPIs Assist in developing and maintaining incident response playbooks and standard operating procedures Monitor the threat landscape to inform detection and response activities Support audits and client due diligence processes where required Unleash your potential To be successful in this role, your background and experience will include: 5+ years’ experience in a security operation, incident response, or SOC analyst role Experience working with (or within) an industry leading MDR/SOC provider Solid understanding of vulnerability management tools and risk-based remediation Familiarity with regulatory and client security expectations in financial services or highly regulated environments Knowledge of attack techniques and incident response frameworks (e.g. MITRE ATT&CK) Bonus: scripting/automation, cloud security experience (AWS/Azure), understanding of data protection principles Industry security certifications are a bonus. Working at Bravura Our people are the heart of our business. We work hard to provide a rich employee experience and a robust framework for ongoing career development. Competitive salary and employee benefits scheme. Flexible working hours, we value work-life balance. Maternity/ Parental (including secondary) leave policy. Cab facility available in Delhi/NCR. Meal facility available Free Medical Insurance So, what’s next? We make hiring decisions based on your experience, skills and passion so even if you don’t match every listed skill or tick all the boxes, we’d still love to hear from you. Please note that interviews are primarily conducted virtually and if you require any reasonable adjustments or would like to note which pronouns you use, please let us know. All final applicants for this position will be asked to consent to a criminal record and background check. Please note that people with criminal records are not automatically barred from applying for this position. Each application will be considered on its merits.

Your Tasks & Responsibilities: Plan and execute product risk management activities together with the project management in an agile development. Work with cross functional teams to identify and evaluate potential safety risks and develop risk mitigation measures for hazardous situations which could occur in the use of the medical devices, health software products and components. Track the implementation of mitigations in close collaboration with product development teams to ensure the effectiveness of the risk control measures. Analyze various industry and regulatory sources of information for potentially applicable risks. Participate in the development and review of the product design inputs and outputs with a focus on risk management. Maintain the contents of the product risk management files. Participate in internal and external audits or assessments. Support continuous growth in excellence of our risk management community and our risk management processes. Qualification And Experience: B.E. / B.Tech / M. Tech Knowledge and Experience: 12-15 years of experience in the medical device industry of which minimum 3 years of risk management experience in SaMD (Software as a Medical Device) is preferred. You have methodological and practical experience in risk management for medical device and health software. You have advanced knowledge about the medical device and its operation/use in customer environment. Good knowledge of relevant product standards such as DICOM, HL7, IHE and clinical workflows is desirable. You know relevant standards and regulations of risk management, e.g., MDR, ISO 14971, IEC 62304, IEC 82304, IEC 62366, ISO 13485. You have experience of working in geographically distributed teams. You have strong communication skills, are assertive and self-motivated with strong analytical and critical thinking skills.

Date: Jul 4, 2025 Location: Bar Lev, IL, 20156 Company: Dentsply Sirona, Inc Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina, USA. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. Bringing out the best in people As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we’re looking for the best to join us. Working at Dentsply Sirona you are able to: Develop faster - with our commitment to the best professional development. Perform better - as part of a high-performance, empowering culture. Shape an industry - with a market leader that continues to drive innovation. Make a difference -by helping improve oral health worldwide. Quality Assurance Team Lead - Bar-Lev Site, Israel MIS is looking for a dynamic and hands-on Quality Assurance Team Leader to join our QA department. In this role, you will lead QA team members and coordinate key quality assurance activities across the organization. Reporting to the QA Director, you will be responsible for core QMS processes, including CAPA management, complaint handling, supplier quality, internal audits, implementation of statistical techniques, document control, and validation activities. This is a great opportunity to step into a leadership role within a global medical device company, while working in a collaborative and professional environment. Responsibilities: Lead a High-Performing Team: Lead a team of professionals to achieve organizational goals. Provide guidance, coaching, and training to ensure the team's success. Recruit and maintain a high-performing team dedicated to quality excellence. Drive Quality Projects: Lead and drive quality projects to establish and sustain a robust culture of quality. Own and drive deliverables related to quality systems, product quality, and compliance. Collaborate Across Functions: Partner closely with various personnel on the site to drive continuous improvement. Provide cross-functional solutions following identified NC to comply with applicable standards and regulatory requirements. Work with key partners to provide quality-oriented solutions. Monitor Compliance: Ensure compliance with company policies and procedures. Assure that appropriate resources are maintained to uphold compliance and adherence to the Quality Policy. Qualifications: Bachelor's degree in a relevant field At least 3 years of experience in Quality Assurance, with a focus on medical devices 1–3 years of proven experience in a leadership or team management role in Quality Assurance. Strong knowledge of QMS regulatory requirements and quality standards such as: ISO13485, 21CFR820, MDR, MDSAP requirements etc. Excellent communication and interpersonal skills Strong analytical skills Excellent English-language skills in both writing and speaking. For over 30 years, MIS, now a member of Dentsply Sirona group, has been developing and producing advanced products and innovative solutions, aimed to simplify implant dentistry. Through state-of-the-art production facilities, MIS offers a comprehensive range of high-quality dental implants, superstructures, tools and kits, regenerative solutions, and digital dentistry services. Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona. Dentsply Sirona Canada welcomes and encourages applications from all backgrounds, including individuals with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. If you need assistance with completing the online application due to a disability, please send an accommodation request to careers@dentsplysirona.com. Please be sure to include “Accommodation Request” in the subject.

Job Summary: We are seeking a highly skilled and detail-oriented Senior Quality Assurance (QA) Specialist to join our team in a medical equipment manufacturing environment. The successful candidate will be responsible for ensuring compliance with applicable regulatory standards (FDA, ISO 13485, MDR, etc.), leading quality assurance activities across the product lifecycle, and supporting continuous improvement initiatives in both design and manufacturing processes. Key Responsibilities: Ensure compliance with FDA 21 CFR Part 820 , ISO 13485 , ISO 14971 , and EU MDR regulations. Lead and participate in internal, supplier, and regulatory audits. Develop, implement, and maintain QA procedures , work instructions, and quality systems documentation. Support product development teams with design control activities, including risk management, verification, and validation. Lead CAPA (Corrective and Preventive Action) processes and conduct thorough root cause analyses. Oversee Non-Conformance (NC) investigations and support disposition activities. Coordinate supplier quality management , including supplier evaluations, audits, and performance monitoring. Participate in quality review boards (QRBs) and change control processes. Provide QA support during manufacturing transfer and process validation (IQ/OQ/PQ). Monitor and analyze quality metrics , prepare reports, and identify trends for continuous improvement. Train and mentor junior QA staff and cross-functional teams on quality policies and best practices. Job Type: Full-time Pay: ₹30,000.00 - ₹60,000.00 per month Schedule: Day shift Work Location: In person

We are looking for a skilled and detail-oriented QA Executive to join our team. The candidate will be responsible for ensuring the quality and regulatory compliance of medical devices in line with EU MDR 2017/745 and Indian Medical Device Rules (IMDR). This role involves preparing, reviewing, and updating key technical and regulatory documentation and supporting post-market surveillance activities. Roles & Responsibilities Preparation, review, and updating of Technical Files as per EU MDR 2017/745 and Device Master Files (DMF) as per IMDR . Maintenance of General Safety and Performance Requirements (GSPR) documentation in compliance with applicable guidelines. Preparation of Risk Management Plans and Reports as per ISO 14971 and other applicable standards. Development and review of Clinical Evaluation Protocols and Reports (CEP/CER) as per MDR/IMDR guidelines. Preparation and maintenance of Post-Market Surveillance (PMS) , Post-Market Clinical Follow-up (PMCF) , and Periodic Safety Update Reports (PSUR) . Documentation of Design and Development activities, ensuring alignment with regulatory and internal design control requirements. Drafting and reviewing Usability Engineering Protocols and Reports in compliance with ISO 62366. Monitoring, tracking, trending, and reporting of all reportable events , including serious/adverse incidents and field safety corrective actions (FSCA) . Keeping up to date with current national and international regulations, standards, and best practices relevant to the medical device industry. Ensure proper handover of responsibilities to designated personnel during absence. Desired Candidate Profile Prior experience in quality assurance or regulatory affairs for medical devices. In-depth understanding of EU MDR 2017/745 , IMDR , and related standards (e.g., ISO 13485, ISO 14971, ISO 62366). Strong documentation and review skills. Attention to detail with good organizational and analytical abilities. Effective communication skills and the ability to work independently as well as in a cross-functional team.

Position Title: Security Operations Engineer Reports To: Director of Security Operations Security Operations Engineer is a technical subject matter expert responsible for executing key functions of CDK’s Security Monitoring and Response strategy with an automation first mindset . This individual plays a key technical role in our Security Operations organization and enables effective incident response via automated workflow s and efficient threat detection content . Key Responsibilities : 1. Technical Leadership : Exemplify security principles and culture Develop, implement, and tune automation playbooks that enable incident response Effectively partner across security, technology, and business teams Provide technical leadership to the security operations team Develop effective metrics and use them to drive meaningful improvements 2. Automated Detection & Response Work with security operations team members to identify response actions which can be automated to drive efficiency throughout response Build automation workflows to contribute to auditable and efficient incident response Drive continuous improvement in CDK’s detection capability using automation, threat and anomaly detection, coverage assurance, and external threat intelligence Build threat detection queries based on attacker techniques and threat intelligence Support and tune threat detection content and automation workflows based on metrics and security operations feedback 3. Incident Response: Develop incident response playbooks and drive response playbook automation, regularly test playbook effectiveness and drive improvement Lead response to medium or higher criticality impact security incidents in accordance with the incident response plan, and effectively coordinate with internal and external parties Effectively triage and identify root cause of security alerts and incidents Serve as a technical leader for significant security incidents Assure 24x7x365 incident response coverage and escalation processes Regularly update the list of likely security incident scenarios using external threat intelligence, collaboration with internal technology teams, and other data sources 4. Security Posture Improvement Use offensive security techniques and exercises to identify detection and response gaps and drive remediation Regularly practice incident response plans and procedures in collaboration with internal and external stakeholders Required Qualifications: Education: Bachelor’s degree in computer science, information security, or an equivalent experience Experience: Minimum of 6 years in cybersecurity, with at least 3 years in a developer role Expert technical expertise in python, javascript , and powershell Experience building SOAR workflows Experience building and tuning threat detection content Experience leading the response to enterprise security alerts and incidents Strong background in security monitoring, automation, and incident response, preferably in a complex SaaS environment Experience with SIEM tools, process automation, cloud environment monitoring, IDS/IPS, firewalls, EDR solutions, MDR/MSSP providers At CDK, we believe inclusion and diversity are essential in inspiring meaningful connections to our people, customers and communities. We are open, curious and encourage different views, so that everyone can be their best selves and make an impact. CDK is an Equal Opportunity Employer committed to creating an inclusive workforce where everyone is valued. Qualified applicants will receive consideration for employment without regard to race, color, creed, ancestry, national origin, gender, sexual orientation, gender identity, gender expression, marital status, creed or religion, age, disability (including pregnancy), results of genetic testing, service in the military, veteran status or any other category protected by law. Applicants for employment in the US must be authorized to work in the US. CDK may offer employer visa sponsorship to applicants.

Job Description About The Role Exciting opportunity for an experienced Security Incident Responder to join our IT Security teamin Pune. Take a key role in driving success by enabling a seamless, global security incident response capability. This is a full-time, on-site position based in our Baner office. About You You have a curious mindset and are highly passionate about security engineering and the evolving role of AI in this domain. You also have: Experience between 2 to 5 years working as a SOC Analyst, Incident Responder or Detection Engineer. Knowledge applications of security frameworks DFIR, Cyber Kill Chain, MITRE ATT&CK. Confidence and the ability to remain calm under pressure. It Would Be Beneficial If You Possess Understanding of software development practices, DevSecOps, enterprise security tools. Knowledge Artificial Intelligence utilization within the Incident management process. Awareness of regulatory environment and requirements (e.g. GDPR) Experience securing cloud-based services (preferably hosted in AWS or Microsoft Azure cloud environments), combined with insight into vulnerability management and scanning tools. Knowledge of techniques to tune SIEMs, threat hunting, and implementing security best practices. Security qualifications e.g. GIAC Certifications, AWS, Azure, CEH, OSCP. Key Responsibilities Act as Incident Commander, coordinating security incident response across teams and time zones, ensuring seamless handoffs. Collaborate with in-house analysts and MDR partners for timely detection, alerting, and monitoring of security events. Manage and triage security alerts, document incidents, and maintain detailed reports. Develop, maintain, and test Incident Response playbooks while driving process and capability improvements. Design use cases for automation and AI to enhance incident management speed and efficiency. Review and optimize security platform configurations, ensuring compliance, stability, and alignment with IT best practices. Benefits and Perks Join us for a rewarding career with competitive compensation, leave entitlements, health coverage, and financial security. Enjoy work-life balance, growth, and recognition for your exceptional performance. Our team will unveil the intricacies of our benefit package during the selection process. Company Overview Hansen Technologies (ASX: HSN) is a global software and services provider, serving energy, water/utilities, and telecommunications industries. With customers in 80+ countries, we foster collaboration across 36 global offices. From 5G advancements to renewable energy transitions, we empower customers to overcome challenges, innovate, and drive new business models. Contact Us If you possess the desired skills and enthusiasm, please “Apply Now” via the link or visit our career page. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status . Visit our website at hansencx.com for more information.

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Quality Engineer II for risk management & PSUR activities support for CST OU A Day in the Life Collaborating with cross-functional teams to develop comprehensive product risk management files, including the risk management plan, Hazard Analysis, DFMEA, and risk management report, adhering to ISO 14971 standards. Responsible for maintaining highest standards of product reliability and patient well-being through gather and analyze data, write reports, and communicate with regulatory agencies on ensuring product safety. Must Have Capability to conduct thorough reviews of new and modified product design documentation, assessing quality characteristics such as manufacturability, serviceability, testability, reliability, and compliance with product requirements. Subject matter expert in risk management for designated medical device products or platforms. Ensuring compliance with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant industry standards during product development and changes. Reviewing Design History Files and Technical Files to ensure alignment with applicable requirements. Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices and independently develop Periodic safety update plan and reports. Partner with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities. Continuously monitor and stay updated with evolving safety regulations and guidelines to ensure PSUR compliance. Familiar with Literature review, PMCF, IMDRF coding, CAPA and NCMR. Hands on experience in signal evaluation trending and reports, preliminary code reviews for the product complaints on periodic basis. Delivering presentations on project status and issues to the QA organization and providing training to other departments on relevant procedures and policies. Participating in audits and demonstrating the ability to effectively contribute as a team player in various roles, including contributor, subject matter expert, leader, and facilitator. Provide Quality support to facilitate resolution of product complaints and/or safety issues Previous experience working in a cross-functional team environment. Familiar with statistical software tools (Minitab) Develop templates and trainings based on the quality system regulations, applicable standards and guidance. Independently review all deliverables to ensure compliance with development process and the standard. Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator. Hands-on experience on complaints analysis, Post market surveillance, Design Controls for Medical Devices. Minimum Qualification B E or B.Tech in Mechanical/Biomedical Engineering Minimum 4-6 years of quality engineering experience or equivalence and overall 6-8 years of experience Key Technical Competencies Familiar with ISO 9001, ISO 13485, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive. Good verbal and written communication skills Understanding of post-market surveillance processes and adverse event reporting. Knowledge of risk management principles and hazard analysis in the context of medical devices. Nice to Haves ASQ CQE, CQA, CSQE and/or CRE certification. ISO 9001 Internal Auditor / Lead Auditor Certification ISO 13485 Internal Auditor / Lead Auditor Certification Lean Six Sigma Green Belt or Black Belt Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Responsibilities may include the following and other duties may be assigned Evaluates incoming complaint information and maintains the record in the electronic database. Performs follow up activities to obtain additional information. Use and maintain database(s), provide analysis and trending data all on complaints. Determines Reportability of complaints to Government Agencies. Identify and document appropriate complaint categories to assure trend accuracy within the complaint database. Writes investigation summaries based on technical product analysis information provided; Ensures record documentation is maintained in a constant state of audit readiness per internal policies. Liaison with groups who perform additional investigation and who prepare written record of investigation. Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing. Provide basic technical expertise and assistance in handling complaints to comply with current FDA and International reporting regulations. Reviews and interprets risk management documentation as it applies to the complaint event. Interacts with multiple departments within Medtronic - MITG, such as Technical Services, Failure Investigation, R & D, Manufacturing and Engineering. Interacts with groups external to Medtronic - MITG, such as customers, vendors, health care professional Required Knowledge and Experience Bachelor degree; Engineering (e.g. SW,EE, ME, Biomedical Engineering) 0-2 years quality assurance or regulatory experience in medical or pharmaceutical industry. Computer literate with skills in Word, Excel, Access, PowerPoint and database trending analysis Strong typing skills and ability to write business documents with minimal supervision. Strong verbal and written communication skills and ability to work in a team oriented environment Ability to multitask. Ability to understand the functionality / intended use of complex medical devices. Minimum travel may be required Nice to Haves Knowledge of medical devices, their development and quality control. Knowledge of FDA, MEDDEV, Canadian Regulations. Technical Writing experience. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Hyderabad Job ID: SS202500077 Function: Quality Role: Regulatory Affairs Desired Skills: Regulatory, EU-MDR, Document, International Job Description Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization. Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects. Develop Regulatory Strategies for new or modified products for assigned projects. Bachelor’s degree in medical, Mechanical, Electric Life Science or other healthcare related majors Good relevant experiences for RA role in medical device and or pharmaceutical industry Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements.

Job Description Job Overview: The Civil/Structural Designer provides solutions to problems in the Civil/Structural Design discipline without supervisory approval and will evaluate and select solutions from established operating procedures and/or scientific procedures. Responsibilities Key Tasks and Responsibilities: Prepare and develop arrangement and detail design drawings of high technical quality and professional consistent presentation, ensuring clarity and ease of construction Develop 3D models Ensure work complies with MDR and project QA and/or QC systems and procedures Apply basic technical skills and knowledge to complete assigned work Continue developing skills to efficiently complete repetitive tasks Manage own time to meet deadlines set by others Become fully familiar with the Project Scope of Work, specifications, schedule, and inter-discipline requirements, including identifying concerns as early as practicable and taking appropriate initiatives to address them Prepare Civil and Structural layouts from data generated by others, in close liaison with Civil and Structural Engineers and counterparts from other disciplines Ensure that the work is carried out in accordance with McDermott requirements, Client and Statutory Design Codes, Standards, or Procedures with a particular focus on Health and Safety Policies Develop 3D Models and ensure clash free model in coordination with all other disciplines' requirements Organize own design work Check designs, with particular emphasis on interfaces with other disciplines Provide drafting support as required Review other discipline drawings Review supplier drawings Reports To: Project: Lead Designer, Lead Engineer Functional: Supervising Department Manager Liaise With: Engineers, other Designers, and Senior Designers Supervises: Associate Designers Qualifications Essential Qualifications and Education: High School graduate with a diploma in Civil or Structural disciplines or equivalent experience 3 years minimum with a major contractor or consultant Knowledge of associated industry detailing standards Knowledge of 2D and/or 3D drafting systems (AutoCAD and/or MicroStation) Knowledge of E3D and/or S3D Knowledge of AutoCAD and/or Auto lisp Programming, 3D Modeling, and 2D Drafting Menu and/or Macro compilation skills Eager to learn Working knowledge of English, both oral and written HSE, TQM, and cost-conscious Show flexibility and ensure proper hand-over with regards to: The reassignment to other departments, construction sites, and fabrication yards The replacement of colleagues during illness and holidays The provision of assistance to other colleagues with heavy workloads (also other projects) when possible/desirable The managing/learning of future current working methods and software applications Is familiar with the use of codes and standards About Us Our ingenuity fuels daily life. Together, we’ve forged some of the most trusted partnerships across the energy value chain to make what was once just an idea a reality: laying subsea infrastructure thousands of feet below sea level, installing platforms hundreds of miles from shore, using our expertise to design and build offshore wind infrastructure, and reshaping the onshore landscape to deliver the energy products the world needs safely and sustainably. For more than 100 years, we've been making the impossible possible. Today, we're driving the energy transition with more than 30,000 of the brightest minds across 54 countries.

Key Responsibilities: Supervise and manage daily production operations for nephrology-focused medical devices, ensuring alignment with the production schedule and quality requirements. Lead a team of production supervisors, operators, and technicians; assign responsibilities, monitor performance, and provide necessary training. Ensure all manufacturing processes comply with ISO 13485, GMP, FDA 21 CFR Part 820, EU MDR, and local regulatory guidelines. Collaborate with Quality Assurance, R&D, Maintenance, and Supply Chain teams to meet production goals and resolve issues. Monitor key performance indicators including productivity, yield, scrap rate, downtime, and on-time delivery. Drive continuous improvement initiatives such as Lean Manufacturing, 5S, Six Sigma, and Kaizen to optimize efficiency and reduce waste. Maintain accurate production documentation, batch manufacturing records, and device history records (DHR). Participate in internal and external audits; ensure CAPA implementation for production-related observations. Assist in process validations equipment qualification, and new product industrialization. Monitor inventory levels of raw materials, WIP, and finished goods in coordination with the inventory and planning team. Ensure safe working conditions and compliance with health, safety, and environmental standards. Required Qualifications & Experience: Bachelor’s degree in Mechanical, Electrical, Biomedical, or Industrial Engineering or equivalent technical field. 6–10 years of experience in medical device manufacturing, with at least 2 years in a supervisory or managerial role. Experience with nephrology devices is highly preferred. In-depth understanding of GMP, ISO 13485, and other medical device manufacturing standards. Familiarity with ERP systems (e.g., SAP), MES, and documentation tools. Skills & Competencies: Strong leadership and team management skills. Ability to troubleshoot technical issues on the shop floor. Excellent planning, organizational, and decision-making abilities. Good knowledge of lean tools and process optimization. Effective communication and interpersonal skills.

Key Responsibilities: Develop and execute global regulatory strategies for nephrology medical devices. Prepare, compile, and submit regulatory filings including 510(k), CE Technical Files, MDR submissions, and country-specific dossiers. Maintain up-to-date knowledge of relevant global regulations including FDA, EU MDR, ISO 13485, MDSAP, and local regulatory frameworks. Serve as a regulatory representative in cross-functional product development teams. Ensure regulatory compliance throughout the product lifecycle, including labeling, advertising, change control, and post-market surveillance. Act as primary contact for regulatory agencies during audits, inspections, and query responses. Develop and maintain Regulatory Intelligence specific to nephrology devices. Provide regulatory support for clinical trials, if required, including ethics committee submissions and clinical evaluation reports. Review and approve product labeling, IFUs, and promotional materials to ensure regulatory compliance. Lead internal regulatory audits and support third-party audits. Train cross-functional teams on regulatory policies and changes impacting the nephrology product portfolio. Required Qualifications & Experience: Bachelor’s or master’s degree in pharmacy, Biomedical Engineering, Life Sciences, or a related field. 7+ years of experience in Regulatory Affairs, specifically in the medical device industry. Strong experience in Class II / Class III medical devices, preferably with nephrology products. Proven track record of successful regulatory submissions in US, EU, and ROW markets. Working knowledge of ISO 13485, 21 CFR Part 820, EU MDR, and global regulatory requirements. Experience with regulatory software/tools and e-submissions is an advantage. Skills & Competencies: Strong understanding of medical device development and regulatory pathways. Excellent written and verbal communication skills. Strong project management and leadership skills. Ability to work cross-functionally with R&D, QA, Clinical, and Marketing teams. High attention to detail, with strong organizational and documentation skills. Ability to influence regulatory strategy and decision-making.

Description At AliveCor, we imagine a healthier world powered by access to personalized intelligent information. Heart disease kills more people than anything else in the western world, including all cancers combined. We're on a mission to be the worlds heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical EKG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, hundreds of thousands of users have taken more than 100-million heart health measurements and counting. AliveCor seeks a Senior Regulatory Affairs Specialist to join this exciting start-up that is changing the face of mobile health. In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction. You will work closely with Quality, Engineering, Product Management, Marketing and Sales teams to manage product submissions, perform regulatory pre- and post-market analysis, drive product registrations and listings worldwide, and help implement and maintain an ISO 13485 and FDA compliant Quality Management System. If you have what it takes to drive change in the medical marketplace, then this is the opportunity for you. Role & Responsibilities Collaborate and execute regulatory strategies for US, Europe and other global registrations Participate in preparation and review of global regulatory submissions Support government/FDA interactions pertaining to medical device registrations and licensing; Participate in the development of regional regulatory strategy and update strategy based upon regulatory changes; Assist in the review of advertising and promotional materials; Provide regulatory support to cross-functional product development and project teams throughout the product lifecycle; Support or lead regulatory activities required for US FDA, EU MDR, NMPA, PMDA, ANVISA compliance; Support worldwide resellers and distributors with product registrations and renewals; Provide regulatory assessment for manufacturing and design changes; Provide regulatory review and approval of change order packets; Support or lead product regulatory intelligence and risk assessments; Assist in maintaining compliance with product post market requirements; Support post-market regulatory actions taken for the products; Support internal and external audits; Ensure compliance with internal procedures and external regulations and standards; Maintain regulatory and quality records and other controlled documents; and Promote a culture of quality throughout AliveCor Requirements Bachelors degree in Science, Engineering, Math, or medical field or equivalent educational experience pertaining to technical writing, scientific method, and problem solving 4+ years of experience in medical device Regulatory Affairs Experience in regulatory affairs for software devices with AI/machine learning algorithms (SaMD) Participated in the preparation of pre-submissions, 510(k)s or de novo submissions Experience with and knowledge of EU Medical Device Regulations Ability to manage small projects: organised, independent, and results-oriented Superb analytical and excellent communication skills, strong team ethic, and attention to detail Preferred Candidate Profile Advanced degree or Regulatory Affairs Certification from RAPS Process-oriented thinking Supported or lead international submissions (preferably in Asia-Pacific and/or LATAM) Demonstrated competence documenting technical information and communicating it to others Perks And Benefits We strive to make your life outside work as smooth as possible while you're at work, and we offer a long list of benefits to make that happen. Hybrid working model Flexible and generous vacation policy Maternity / Paternity Leave/ Adoption/ Commissioning leave Generous Medical Benefits Above market family floater medical insurance coverage including both parents or in law parents Metro connectivity from office A supportive, collaborative group of people who understand that success depends on the team AliveCor is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any other classification protected by federal, state, or local law.

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Responsibilities may include the following and other duties may be assigned Evaluates incoming complaint information and maintains the record in the electronic database. Performs follow up activities to obtain additional information. Use and maintain database(s), provide analysis and trending data all on complaints. Determines Reportability of complaints to Government Agencies. Identify and document appropriate complaint categories to assure trend accuracy within the complaint database. Writes investigation summaries based on technical product analysis information provided; Ensures record documentation is maintained in a constant state of audit readiness per internal policies. Liaison with groups who perform additional investigation and who prepare written record of investigation. Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing. Provide basic technical expertise and assistance in handling complaints to comply with current FDA and International reporting regulations. Reviews and interprets risk management documentation as it applies to the complaint event. Interacts with multiple departments within Medtronic - MITG, such as Technical Services, Failure Investigation, R & D, Manufacturing and Engineering. Interacts with groups external to Medtronic - MITG, such as customers, vendors, health care professional Required Knowledge And Experience Bachelor degree; Engineering (e.g. SW,EE, ME, Biomedical Engineering) 0-2 years quality assurance or regulatory experience in medical or pharmaceutical industry. Computer literate with skills in Word, Excel, Access, PowerPoint and database trending analysis Strong typing skills and ability to write business documents with minimal supervision. Strong verbal and written communication skills and ability to work in a team oriented environment Ability to multitask. Ability to understand the functionality / intended use of complex medical devices. Minimum travel may be required Nice to Haves Knowledge of medical devices, their development and quality control. Knowledge of FDA, MEDDEV, Canadian Regulations. Technical Writing experience. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Quality Engineer II for risk management & PSUR activities support for CST OU A Day in the Life Collaborating with cross-functional teams to develop comprehensive product risk management files, including the risk management plan, Hazard Analysis, DFMEA, and risk management report, adhering to ISO 14971 standards. Responsible for maintaining highest standards of product reliability and patient well-being through gather and analyze data, write reports, and communicate with regulatory agencies on ensuring product safety. Must Have Capability to conduct thorough reviews of new and modified product design documentation, assessing quality characteristics such as manufacturability, serviceability, testability, reliability, and compliance with product requirements. Subject matter expert in risk management for designated medical device products or platforms. Ensuring compliance with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant industry standards during product development and changes. Reviewing Design History Files and Technical Files to ensure alignment with applicable requirements. Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices and independently develop Periodic safety update plan and reports. Partner with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities. Continuously monitor and stay updated with evolving safety regulations and guidelines to ensure PSUR compliance. Familiar with Literature review, PMCF, IMDRF coding, CAPA and NCMR. Hands on experience in signal evaluation trending and reports, preliminary code reviews for the product complaints on periodic basis. Delivering presentations on project status and issues to the QA organization and providing training to other departments on relevant procedures and policies. Participating in audits and demonstrating the ability to effectively contribute as a team player in various roles, including contributor, subject matter expert, leader, and facilitator. Provide Quality support to facilitate resolution of product complaints and/or safety issues Previous experience working in a cross-functional team environment. Familiar with statistical software tools (Minitab) Develop templates and trainings based on the quality system regulations, applicable standards and guidance. Independently review all deliverables to ensure compliance with development process and the standard. Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator. Hands-on experience on complaints analysis, Post market surveillance, Design Controls for Medical Devices. Minimum Qualification B E or B.Tech in Mechanical/Biomedical Engineering Minimum 4-6 years of quality engineering experience or equivalence and overall 6-8 years of experience Key Technical Competencies Familiar with ISO 9001, ISO 13485, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive. Good verbal and written communication skills Understanding of post-market surveillance processes and adverse event reporting. Knowledge of risk management principles and hazard analysis in the context of medical devices. Nice to Haves ASQ CQE, CQA, CSQE and/or CRE certification. ISO 9001 Internal Auditor / Lead Auditor Certification ISO 13485 Internal Auditor / Lead Auditor Certification Lean Six Sigma Green Belt or Black Belt Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here