15 Design Control Jobs

What this job involves You will be responsible to ensure all necessary utilities are being given to the occupants/tenants. You will be responsible for all drawing submissions and approvals to be maintained for fitout work. The contractor will coordinate with you for all minor execution issues. Building maintenance and upkeep will be one of your KRA. Your key deliverables will be: Maintain records of all building drawing. Make sure all instruction guidelines are being followed as per the fitout manual. Provide necessary permits (Night work, hot work, height work). Coordinate for all necessary security arrangements for execution of fitout activities. Monitor and control work in progress as per approved plan by the client. Ensure completion of Snagging and De-snagging work of flats Common area. Ensure all safety requirements are being followed at the site. Advise contractor on minor execution issues. Ensure that all work meets client design control specifications. Daily visit to ongoing fit-out work for checking of civil work layout. Working closely with management to help improve and maintain the building in clean and maintenance free condition. You will be meeting with all clients who are going to start the fit-out work to resolve queries of clients regarding the working procedures, instruction and for material handling as per approved drawings and other documents related to fit out work and operation activities. Maintain a fitout tracker. Providing the clients with suitable energy conservation plans. Coordinate and maintain the as-built drawing and transition document library. Work closely with the regional RO HO SME/ Training teams and ensure closures of all required reports. Facilitate the services under the Slogan No Safety No Work. Site dynamics: 1. Work Schedule: 2. Site team: e.g.: Property Manager +2 3. Other details if any. Reporting: You will be working with our operations team and reporting to the Property Manager. Sound like you Here is what were looking for: Being Analytical and Meticulous Your role will involve coordination with various teams/ vendors. You will be paying attention to detail and have excellent problem-solving skills. You will be using logic to trouble-shoot problems; and assign and monitor maintenance projects. You should have a good knowledge of the working procedures for fitout. Qualifications You will have a Degree Diploma or relevant educational background in Civil Engineering with minimum 1-2 years of work experience. On-site Mumbai, MH

Verification and Validation R&D Primary responsibilities: Represent the Design Quality function on device development project teams and cross functional co-ordination with multiple departments including R&D, Quality Control, Manufacturing and Regulatory Affairs. Ensure that device development projects and changes to existing devices are conducted in compliance with the FDA 21CFR Part 820 Quality System Regulation, ISO 13485 Regulations, and other applicable standards like ISO 14971. Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting devices can be adequately manufactured and verified. Lead or support design activities including design verification, validation, test procedure development, usability engineering, and risk management. Generate or apply statistical methods with appropriate risk-based justification. Hands-on experience in Design History File compilation / Technical file documentation. Support internal and external inspections/ regulatory audits. Promote continuous improvement in design control activities and use of quality tools with design team. In-depth knowledge and understanding of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, 21 CFR 4 Regulation of Combination Products, 14971 Risk Management Standard, MDD, MDR, IEC/EN 62366 Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices Secondary responsibilities (Wherever applicable): Experience interacting with regulatory agencies and notified bodies Experience with process improvements, process qualification and validation. Experience in complaint investigation, corrective action and preventive action system, statistical methods, quality risk management and Post Market Surveillance.

Your key responsibilities The Senior will support teams of FAAS professionals during engagements covering a broad spectrum of Process and Control areas. The Senior will be responsible for the following tasks: Responsible for executing client related engagements in the areas of governance, risk & compliance (GRC), process reviews, standard operating procedures, enterprise risk management, SOX, Internal Control over Financial Reporting (ICFR). Supporting SOX engagement, Process and Control; or should be an expert in driving Financial Statement Close Process, Procure to Pay and Order to Cash, Inventory, Fixed Assets, PPE & Intangible assets processes (along with experience in Risk management) Supporting projects related to Process Improvement and Implementation, drafting risk and control matrix, process placemats and documenting SOPs. Supporting engagement planning, budgeting, execution and management Preparing products/deliverables meet contract/ work plan specifications and deadlines Supporting the development of tools and methodologies for project delivery Participating in meetings and interviews with client personnel Developing creative, yet practical, solutions to help our clients achieve their Process and Control objectives Developing client deliverables and engagement documentation Developing, tracking and supporting actual engagement economics versus the budget Supporting the development and management of the relationships with external and internal clients Supporting development of new service offerings and go-to-market strategies Supporting other ad-hoc internal initiatives geared towards improving our groups efficiency, effectiveness and integration with other service lines To qualify for the role, you must have Chartered Accountant (CA), CPA (US) or ACCA (UK) with 3+ years of experience with a large Global Corporate Process, Risk and Control department and/or similar experience MBA degree is a plus Experience with the following Process and Control areas: Governance, controls and regulation Governance, Risk & Compliance Process and Control Process reviews Standard Operating Procedures Enterprise Risk Management Revenue Assurance SOX Internal Control over Financial Reporting (ICFR) Design and Implementation testing

Job Description Job title: Quality Engineer, Products and Systems Your role: Be part of Project team and participate in defining product design input, requirements, V&V, output and design transfer requirements and plans. Ensure product quality, compliance and state of art throughout the product lifecycle. Reaffirm that design input are transferred to product design and verified to confirm that design output meet the design input. In collaboration with multi-disciplinary team, lead the design for reliability to create a reliability plan and include the reliability requirements in product design. Ensure that reliability requirements are met through test, verification and validations, as applicable. A distinguished champion on patient safety and quality with expertise on quality and compliance principles like IEC60601, IEC 62304, IEC62366, 21CFR806. You will be acting as subject matter expert to provide guidance on product design quality, safety, reliability, serviceability, maintainability, manufacturability and other aspect in collaboration with business and technical SMEs. Well conversant with QMS requirements in accordance with ISO13485:2016 and ISO14971. Expert in medical device risk management principles including risk evaluation, assessment, risk determination, mitigation and risk benefit analysis. You will be acting as facilitator for risk management activities in accordance with ISO14971 and other applicable regulatory requirements. You're the right fit if: (4 x bullets max) Experience: 12 to 20 Years, minimum 10 years in Medical device industry. Bachelor's in engineering or quality management, with 12 to 20 Years, minimum 10 years in Medical device industry. Proven knowledge of the FDA regulations for Design Controls for medical devices is a must and the combination with (extensive) experience with regulatory inspections has a very strong preference. Product Quality Engineering and Design Control experience is a requirement. Certification in Software Quality Engineering (CSQE) from ASQ or other bodies is desirable In-depth knowledge and a proven track record in implementing and applying concepts in the fields of designing in quality, reliability and problem-solving techniques have a strong preference. Leadership experience and good change management and influencing skills (required) You are Customer, Patient Safety and Quality focused. Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR. Advanced level knowledge of IEC62304, IEC62366 and ISO14971 has a strong preference. Excellent communication skills, able to clearly and concisely summarize complex technical problems You combine analytical and conceptual thinking, physical insight, system view, flexibility and a Handson mentality to deliver sustainable results and creative solutions. You are a motivated self-propelling person, with determination to succeed and the ability to manage change. Excellent organizational skills to lead and track deliverables Strong influencing skills power of persuasion, perseverance, getting things done mentality. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the companyu2019s facilities. Field roles are most effectively done outside of the companyu2019s main facilities, generally at the customersu2019 or suppliersu2019 locations. Indicate if this role is an office/field/onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. u2022 Learn more about . u2022 Discover . u2022 Learn more about . If youu2019re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, Vantive: A New Company Built on Our Legacy Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company Vantive will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us, At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us are driven to help improve patientslives worldwide Join us as we revolutionize kidney care and other vital organ support, Summary The Lead System Integrator (LSI) team is a part of the R&D organization that supports the Kidney Care business segment Within the team, we provide R&D focused project management support for all product phases, innovation initiatives, new product development and improvement programs for existing therapy systems, Vantive is a global company with R&D sites at multiple locations in the world; competences and capabilities are spread over the different R&D sites, and you will commonly collaborate with colleagues across several of these R&D sites and with other functional representatives Work assignments within the team are highly variable and we can promise you a work environment with exciting project management challenges and variability in your day-to-day activities, The Kidney Care R&D Drug Products and Sciences (DPS) organization is responsible for Kidney Care drug products (dialysis solutions, concentrates, etc) and related sciences (Sterility Assurance, Analytical Chemistry, materials compliance, Extractables & Leachables, Toxicology) As a member of the Drug Products and Sciences organization, the Lead System Integrator co-ordinates/leads DPS R&D activities within a Project or Program with her/his Project Management and Technical Leadership skills This role may be responsible for supporting multiple projects, Essential Duties and Responsibilities This section contains a list of five to eight primary responsibilities of the work The incumbent will perform other duties as assigned, Lead research and development (R&D) project management work for drug products, medical devices, and other regulated healthcare products Owner of R&D program schedule creation, tracking, and execution Integrate inputs from all DPS competencies/subject matter experts into a harmonized project proposal, project schedule, technical risk assessment, and other project plans, Participates as a member of cross functional teams and/or integrates cross functional inputs into project deliverables Accountable for project execution and proactive risk management Effectively tracks project status, risks, budget, and external spend, Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards Prepares project reports, analyses and delivers presentations to R&D leadership on a regular basis Leads scheduled meetings in R&D, develops and manages agenda, creates minutes, and follows up action items throughout the project Establish project communication channels and archives e-g , Teams group, Status meetings, Escalation matrix, etc Facilitate/organize DPS R&D project design reviews and change control meetings Facilitate purchase orders (POs) and approve corresponding invoices for the R&D tasks executed by external vendors (e-g , external labs, translation agencies, etc ) Across multiple parallel projects, identify and evaluate interactions/dependencies and potential synergy opportunities Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily List knowledge, skills, and/or abilities required, Experience in project management principles and methodologies Strong interpersonal and communication skills in written and verbal form Demonstrated ability to draw conclusions and make recommendations based on technical inputs from multiple and varied functions (Marketing, Quality, Regulatory, etc ), Ability to provide technical leadership and coordination for medical product projects with substantial complexity and scope, Ability to decompose complex problems into actionable plans and track them to closure Understanding of design requirements for development, validation, and verification of medical products Education and/or Experience Include the education and/or experience that is necessary to perform the job satisfactorily, Bachelors degree in Engineering, Science or related field 10+ years of relevant R&D, Project management (or similar) experience preferred Experience in pharmaceuticals or medical product industry preferred Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice,

HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission - to serve patients - drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. Regulatory Affairs Manager – Devices What you will do Let’s do this. Let’s change the world. In this vital role you will support development and execution of regulatory strategies and filings for new and existing drug delivery devices and combination products, establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. Responsibilities: Support the development, communication, implementation, and maintenance of JAPAC regulatory strategic plans Lead and/or support JAPAC health agency engagements Lead and/or support JAPAC filing activities and associated health agency inquiries Support device design controls activities and documentation reviews Assess device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions in the JAPAC region Perform change control regulatory assessments as it relates to JAPAC Develop and support implementation and maintenance of internal regulatory processes Perform device determination decisions for regulated items to be developed and/or used in JAPAC region Support supplier engagement teams and due diligence activities in the JAPAC region Review regulatory sections in development, quality, and supply agreements that impacts JAPAC region Support regulatory compliance initiatives in the JAPAC region What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Regulatory professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree; or Master’s degree and 2 years of pharma/biotech and/or medical device regulatory affairs experience; or Bachelor’s degree and 4 years of pharma/biotech and/or medical device regulatory affairs experience Preferred Qualifications: Master’s degree in regulatory affairs, engineering, or life sciences 6 or more years of experience in medical device regulatory affairs Experience in design controls, manufacturing, process development, quality assurance, quality control, or analytical development Experience in drug delivery device or diagnostics device regulatory submission process Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms

Security Architect Selected candidate to support our client, APAC based Investment bank, in Security Architect profile. Our client is seeking a highly skilled and proactive Security Architect to play a crucial role in their team ensuring the security and compliance of project / application implementation, with a particular focus on Cloud services and technologies for all business units. KEY RESPONSIBILITIES Conduct security-by-design reviews on new programs, initiatives, projects, Cloud services and technologies regionally (in-house development, Commercial Off-The-Shelf, SaaS), ensuring sufficient documentation for compliance / audit. Collaborate with Group and Regional information security teams, as well as business stakeholders, to ensure project implementation aligns with security controls in accordance with policies, standards, guidelines, and regulations. Take part in the security architecture blueprint and design review process for the Cloud hosted solutions. Ensure critical vulnerabilities are tracked and remediated prior to application go-live. Analyse, review, and approve non-standard software/technology implementations regionally. Perform ad-hoc and periodic reviews of Proxy/Network/Firewall requests, designs, and configurations in client network. Provides advisory and consultation to business units, business owners, and project teams for any Cloud Security related matters. Create a culture of security-by-design awareness by conducting related training for LBUs and other relevant stakeholders. Create, maintain, and update relevant security policies, standards, and operating procedures for client. Support the team leader with any assigned security operation tasks related to endpoint security, network security, data protection, DLP, VAPT, security alerts, and incidents. EXPERIENCE / QUALIFICATIONS Recognized degree in Computer Science or related Engineering fields. 5-10 years of demonstrated experience in reviewing and identifying gaps in architecture blueprints and designing controls, especially in the Cloud domain. Candidates with proven experience in financial services industry is preferred. Must be able to recommend mitigations to threat models based on threat vectors and exploits. Good knowledge and experience with regulations, including PDPA, MAS guidelines, and technology/cybersecurity regulations in other Asian countries (e.g., Thailand, Malaysia, Taiwan). Understanding of asset and/or wealth management businesses, including trade lifecycle and operational processes, is a plus. Certifications such as CISA, CISSP, and CCSP are encouraged and demonstrate continuous learning and application of standard methodologies. Ability to understand business requirements and security risks during security assessments and consultations. Understanding of the company's business direction from products, solutions, market, and technology perspectives in the Cloud domain. OTHER TRAITS Possess exceptional problem-solving and data analysis skills. Positive attitude and collaborative mindset. Highly motivated to stay updated with the latest developments in technology-related regulations and to acquire broad technical knowledge and skills. Strong communication, presentation, and interpersonal skills; ability to work collaboratively and effectively with employees at all levels in different geographies. A good team player in managing internal and external stakeholders to resolve issues and align with objectives. Exhibit proactiveness in identifying, articulating, and remediating gaps and issues.

Location : Gurgaon Designation : Senior Engineer: Requirement Management/JAMA Administrator Requirements : The Engineer will assist in the ongoing adaptation and deployment of new tools such as JAMA. The administrator will work closely with functional leaders, organizational units, and subject matter experts to identify develop and deploy new business processes. This role is part administrator, part quality analyst and part trainer. The Administrator will be responsible for executing on the day-to-day configuration, support, maintenance and improvement of the tools, qualification of the tools and associated processes. The Administrator will manage the relationship with the software vendors and be responsible for documenting and updating internal processes and procedures, in relation to these software tools, for the quality system. We would love to have you on the team if you are a self-starter with a strong project organization skill set, have a firm grasp of the design control process common in regulated industries, and are motivated to work in a highly technical, fast-paced, and cross-functional environment. What you will do: Work independently with members of the business to define and document the scope of new development requirements in an Agile environment. A demonstrated ability to understand and articulate complex requirements Ability to critically evaluate information gathered from multiple sources, reconcile conflicts, decompose high-level information into details, abstract up from low-level information to a general understanding, and distinguish user requests from the underlying true needs Ability to assess the impact of new requirements on all upstream and downstream applications, systems and processes Work with our management team to establish suitable processes to support administrative, development, and change management activities Document standards, guidelines, templates, and best practice procedures for both administrators and users of the system. Administrative owner of the tools such as Jama software requirements management tool Perform and own tasks including, but not limited to: User account maintenance Create filters and custom reports or dashboards for each project, as needed. Customize workflows for multiple projects and maintain configuration of the tools. Manage release cycles and validate the software tools. Upgrade, backup, and baseline the project folders within each software tool. Work closely with Quality engineering team for compliance. Demonstrated ability to meet deadlines, handle and prioritize simultaneous requests, and manage laterally and upwards Creative and analytical thinker with strong problem-solving skills Must demonstrate exceptional verbal and written communication skills Must demonstrate ability to communicate effectively at all levels of the organization Previous experience working in a SCRUM or Agile environment preferred Previous software development experience is preferred Minimum Qualifications (Required): Bachelors degree in computer science, Computer Engineering or related field is preferred and minimum of 2+ years of experience as a Software/Quality Engineer in a regulated industry. Preferred Qualifications (Strongly desired): Knowledge of JAMA workflows or similar tools like JIRA. DOORS, IBM SYNERGY, PTC INTEGRITY Understanding of engineering lifecycle phases and design control processes is preferred. Proven ability to design and implement new processes and facilitate user adoption. Knowledge of Requirement Management and Test Management, Traceability. Experience validating third party tools to comply with Quality Management system and to follow FDA guidance is preferred. Experience with software and hardware defect tracking processes is preferred. Ability to communicate and work with external software vendors is preferred. Ability to work independently and manage priorities on multiple tasks is required. Excellent verbal and written communication skills is required. Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820 is preferred Interested candidates please reach on - HR Sonali - 8879984232 OR Share updated profile on sonali.patne@enlinkit.com

About Alkem MedTech Pvt Ltd: Alkem MedTech Pvt Ltd is a wholly owned subsidiary of Alkem Laboratories Ltd, which is the 5th largest listed Pharmaceutical company in terms of market share. As the first MedTech venture of Alkem Labs, Alkem MedTech is dedicated to advancing precision, high-risk, and implantable medical devices along with their accessories. MedTech is a strategic priority for Alkem Labs, representing a significant growth avenue. We are beginning our MedTech journey by focusing on Musculoskeletal solutions and have plans to expand into multiple segments, establishing a robust, multi-faceted MedTech company in the near future. Alkem MedTech will be manufacturing in India, aligning with the vision of the Government of India to boost domestic production and innovation in the medical technology sector. We are looking for passionate and innovative talents to join our pioneering team. If you are excited about shaping the future of medical technology and want to be part of a transformative journey, Alkem MedTech is the place for you. Why Join Us? Innovation-Driven Environment : Work on cutting-edge technologies in precision and implantable medical devices. Growth Opportunities : Be part of a strategic growth initiative for one of the leading pharmaceutical companies and be part of creating a legacy. Collaborative Culture : Engage with a team of dedicated professionals committed to making a difference in healthcare. Impactful Work : Contribute to life-changing medical solutions in the Musculoskeletal segment and beyond. Manufacturing in India : Support the vision of the Government of India by contributing to domestic production and innovation in the MedTech sector. Join us at Alkem MedTech and help shape the future of healthcare technology. Purpose of the role: The Design Quality Engineer will be responsible for ensuring the design, development, and manufacturing processes comply with regulatory requirements, industry standards, and company quality policies. This role will involve close collaboration with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Quality Assurance. Roles & Responsibilities: Ensure design control activities comply with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485) and standards (e.g., ISO 14971, IEC 62366). Participate in design reviews and provide quality engineering support throughout the product development lifecycle. Establish and maintain Design History Files (DHF) and Risk Management Files (RMF). Conduct design verification and validation activities, ensuring product safety and efficacy. Develop and implement risk management activities including Failure Mode and Effects Analysis (FMEA). Collaborate with cross-functional teams to ensure effective design transfer from R&D to manufacturing. Support the creation and review of technical documentation, including design inputs/outputs, specifications, and reports. Manage non-conformances, CAPAs, and change management activities related to design quality. Provide guidance on regulatory requirements and standards related to orthopedic implant design. Participate in internal and external audits, including regulatory inspections.

We are Qatar based company and follow GCC calendar Working schedule: Saturday to Thursday. Friday is the holiday. Office timing:10 AM to 8 PM Roles and Responsibilities Manage engineering control documentation, ensuring accuracy and compliance with industry standards. Collaborate on team projects by creating PowerPoint presentations, Word documents, and RFQs as needed. Maintain databases for project management, change management, and document control. Develop and implement effective document management processes using advanced Excel skills. Provide technical support through MS Office applications. Engineering Changes & Control Prepare quotation for client Quality Control of Documentation: Reviewing documents for errors or inconsistencies and ensuring that quality assurance standards are met across all engineering documentation. Issue Resolution: Quickly addressing any issues related to missing documents, incorrect data, or miscommunications regarding design changes, ensuring a smooth workflow. Version Control: Ensuring all documents are versioned correctly, maintaining a clear history of changes, and preventing errors related to outdated information. Ensuring Regulatory Compliance: Ensuring all engineering documents and designs comply with industry standards and regulations (e.g., ISO, ASME, etc.), and maintaining records of compliance for audits.

Client Location: Tower B, 16th Floor, Prestige Shantiniketan, Bangalore North, Bangalore, 560048 Role: Tester - Skill Set 3 Senior Client Domain: Healthcare, Medical Devices manufacturing Business Unit: Kidney Care - Kidney Care Multi Division (158-105) Job Description: Essential Duties and Responsibilities: Contributes through demonstrated hands-on participation in Leading Engineering Change controls & Testing activities. Exposure to GDP and GMP is must. Hands on Experience in handling Mechanical Equipment like UTM, Leak Tester, Torquer Tester and other instrument and Equipment would be added advantage Ability to write testing protocols independently with minimum guidance. Hands on experience in Creo or SolidWorks is must. Responsible for Design and Development of fixture per V&V needs by preparing drawing and working closely with external vendors. Responsible & Accountable for project deliverables. Lead all DHF tasks & Risk management tasks Hands on. Work with Cross Functional Teams Globally ensure completion of Cross functional tasks. Experience in Handling Plastic components, Design of Connectors is preferred. Exposure to Regulatory Standards and Manufacturing process and procedure for Medical Devices. Exposure to RF welding, Solvent bonding process would be an added benefit. Exposure to statistical tools like Minitab and Six sigma methodology for results analysis would be an added advantage. Ability to Plan DoE to resolve any issues to technical discussion and support and product install based. Ability to conduct verification and validation tests to support changes as per QMS process. Ability to do project planning for Leading the installed base tasks. Ability to resolve to field issue - Perform NCR/CAPA. Responsible for completion of MDR activities related to assigned families. Responsible for executing all assigned test with minimal dependency on owners by considering testing timelines, providing frequent updating of test results to owners, and ownership in preparing final report by routing, review signoff and releases. Qualification: BE in Mechanical Engineering with 7 to 10 years of experience in Medical and Aerospace Domain.

Job Description Summary Job Description Experience with 3-5 years in medical devices and in related industries The R&D Senior Engineer will be a key contributor on a R&D team within BDSpecimen Management The individual in this position will have a complete understanding of a wide application of technical principles, theories and concepts He/She provides solutions that are imaginative, thorough and practical to a wide range of complex problems Works under general direction Independently determines and develops approach to solutions Contributes to a project of considerable significance or leads smaller scope projects Supports material/design/process changes to the product line through design control process, with well documented research/analyses Demonstrates accountability for successful and timely completion of designated tasks Develops technical solutions to complex problems using sound engineering principles, utilizing experimental, computational and analytical methods Designs and develops in vivo and in vitro models to evaluate product features and improvements Applies innovative & logical risk based approach to product development challenges with the capacity for original thinking Develops robust test methods, design test fixtures and execute measurement system analysis Ensures compliance with BD quality policies, procedures, and practices through appropriate communication, training and education of sound quality assurance principles Plans, executes and analyzes design of experiments (DOE) Writes implements and leads bench studies, tolerance stack up analysis, design verification, validation, vendor interactions, materials specifications and component specifications Performs data analysis using statistical tools, regression analyses and develop transfer functions Collects, records, reports, interprets and analyzes data, presents results to peers and business leadership Provides advanced engineering skills and product evaluation support to the platform toward building business cases for new opportunities Required Skills Optional Skills Primary Work Location IND Bengaluru Technology Campus Additional Locations Work Shift

Job Requirements Review design layouts/3D models that graphically show how the product is to function. Check assembly drawings and piece part drawings that further break down the consist of the product definition. Collaborate with engineering design team. Ensure Engineering notices are filled out properly and that they convey all necessary information. Confer with design personnel to answer the questions pertaining to engineering practices and standards. Provide counsel, advice to design control personnel on potential problems during design review phase. Check redesigns cause by field problems. Good Problem-Solving Skills, Technical Know-how ability, Accountability. Self-Motivated/Team Player. Ability to communicate effectively. Developing standard work instructions and deploying and updating the best practice process documents & templates for complex drawings. Also, this position requires counsel and advice to design control engineers on potential problems due to the form, fit and functional errors during the Product design phase. Work Experience Bachelor degree in an accredited Mechanical Engineering curriculum. 5 to 8 years Engineering experience. Familiarity with Creo 4.0 detailing/modelling practices. Working Knowledge on PLM Tool (Preferred Windchill). Background in drafting and technology. Strong competency in Sheet metal design manufacturing processes.

We are actively seeking exceptional candidates to join one of the largest medical device company globally, recognized as a leader in medical, scientific, and imaging technology products. This presents an excellent opportunity to become a part of the Core R&D team in Hyderabad, focusing on New Product Development (NPD) Programs. If you believe you are a suitable candidate, please submit your most recent resume. The job description is provided below for your reference. Person Specification: Education A degree or higher qualification in Biomedical / System Engineering from a recognized university. Masters in biomedical /system engineering will be an added advantage. Experience 4-12 years of experience in System Engineering R&D in the medical devices domain, with a mix of technical and managerial responsibilities Proven experience in collaborating with PMOs and global teams on system projects Strong technical background in system design, circuit board development, and compliance with regulatory standards Experience in medical device development is preferred Skills Strong technical expertise in systems engineering, systems modeling, and requirements management, with hands-on experience in R&D and/or sustaining engineering, especially in product development environments Expertise in systems engineering methodologies, including requirements management, risk analysis, and system integration Familiarity with medical device product lifecycle management, with experience in applying FDA Design Controls and international standards (e.g., 820-CFR, ISO14971, IEC60601), ensuring compliance with project-specific regulations Experience with model-based systems engineering (MBSE) tools and methodologies Comfortable working in Agile SCRUM and stage-gate environments, ensuring collaboration with cross-functional teams to meet project objectives Ability to develop and contribute to design documentation, including requirements specifications, risk management files, and compliance records for manufacturability and quality assurance Knowledge of systems integration and architecture, contributing to design solutions to mitigate risks Understanding of software lifecycle management (e.g., EN62304) and experience with managing system-level risks and verification Experience with requirements management systems (e.g., DOORS, JAMA), contributing to risk analysis and DFMEA processes in system R&D projects Effective stakeholder management skills, collaborating with PMO teams to ensure technical alignment and timely project delivery Experience working with project data, contributing to technical assessments and identifying opportunities for process improvements and operational efficiency Strong communication skills, with the ability to present technical updates and information clearly to cross-functional teams and stakeholders

Looking for a challenging role? If you want to make a difference - make it with us Can we energize society and fight climate change at the same time? At Siemens Energy, we can. Our technology is key, but our people make the difference. Brilliant minds innovate. They connect, create, and keep us on track towards changing the world"™s energy systems. Their spirit fuels our mission. Our culture is defined by caring, agile, respectful, and accountable individuals. We value excellence of any kind. Sounds like you? We make real what matters. This is your role As an Engineering specialist, design control philosophy and wiring schematics for EHV and HV AIS circuit breakers. Responsible for preparing engineering documents, discussions with customers regarding open points, and arranging drawing approvals by conducting meetings/customer visits to customers like PGCIL, NTPC, and other major utilities. Take handover from the Sales/Order Acquisition team and understand all documents and specifications to provide engineering documents in line with agreed technical parameters. Checking and maintaining/configuring SAP BOM for all Circuit Breaker and spare orders. Spares and internal order booking/customer complaints booking in SAP and maintaining bill of material. Understanding non-standard requirements and circulating correct information about the drawings through manufacturing instructions. Engage with internal stakeholders to clear all engineering documents, Bills of materials, SAP codes, etc. What you need to make real what matters You should be a graduate/postgraduate in Electrical engineering, have sufficient product knowledge, and 3 to 5 years of industry experience. You should have Strong strategic planning, negotiation, customer intimacy, organizational skills, proactiveness, strong decision-making, ownership mindset, and soft skills. Excellent analytical and problem-solving skills with the ability to manage multiple disciplines simultaneously. Knowledge of Auto CAD, E-Plan, CAD Worx E&I, and SAP. You"™ve good knowledge of High Voltage Circuit breakers of Air Insulated Substations. We"™ve got quite a lot to offer. How about you? This role is based in " Aurangabad ". You"™ll also get to visit other locations in India and beyond, so you"™ll need to go where this journey takes you. In return, you"™ll get the chance to work with teams impacting entire cities, countries and the shape of things to come. We"™re Siemens. A collection of over 379,000 minds building the future, one day at a time in over 200 countries. We're dedicated to equality, and we welcome applications that reflect the diversity of the communities we work in. All employment decisions at Siemens are based on qualifications, merit, and business needs. Bring your curiosity and imagination and help us shape tomorrow.