130 Iso 13485 Jobs

Job Description The Software Quality Engineer is responsible for Software Quality relative to the design and development of company products, software reliability, developing and maintaining processes and procedures, and assuring adherence to the software development lifecycle across Abbott. Responsible for maintaining a strong collaborative partnership with cross-site and cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. About the team: The Software Quality Engineering team provides a fast-paced, dynamic work environment where engineers work closely with cross functional teams to provide software services to patients and physicians while keeping Quality foremost on our mind. You will collaborate with other engineers in in from the various R &D teams to continue finding new areas that can be improved by bringing a while also conducting testing, ensuring compliance with regulatory standards, and integrating best practices in the Quality Management System. We re passionate about building products that improve the quality of life for patients. We like to learn along the way and depend on everyone s input to help us grow as a team. Position requirements: Bachelor s Degree ( 16 years) in Computer science, software engineering, or a closely related discipline Or Master s degree. Minimum of 4 years of related work experience in quality or related field. Minimum of 3-5+ years of combined experience in software development web-based, client-server, and/or embedded systems applications Minimum 3-5+ years of combined experience in software testing andverification/validation Experience developing automation frameworks and scripts using Selenium, and/or Appium, UFT, etc. Programming experience in C/C#/Visual Studio/Java, Scripting Language such as Python, Ruby, Perl Experience with software configuration, and issue tracking tools such as GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla. Experience as team-member in Agile SDLCprojects/programs Knowledge of various types of SDLC s and TLC s (V-Model, Iterative, Agile/Scrum, etc.) Working experience in behavior-driven testing and scripting using cucumber or behave. Experience in automated test execution using Selenium and Appium. Ability to follow processes per defined Quality Management System Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes, and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Good to have: Experience using overall test management tools such as Microfocus ALM, Zephyr, Test Complete. Experience in code review/static analysis tool(s) to aide code review such as Code Collaborator, Coverity, Parasoft DT Experience working in a broaderenterprise/cross-divisionbusiness unit model. Working experience in mobile test automation tools (e.g. Perfecto, MobileLabs) Working knowledge of 21 CFR part 820, IEC 62304, IEC 82304-1, ISO 14971, and ISO 13485

Job Description Position: Associate Junior Executive Manufacturing Position Reports to: Manager Manufacturing Downline Reporting: Operators Department: Manufacturing Location: Jigani, Bangalore India Job Responsibilities: To achieve Daily / Shift targeted production at required quality levels at specified costs in conformance with procedures specified in the quality system by ensuring availability of manpower, machines, and materials. To deliver products on time to the internal customers as per the production plan duly tying up suitable manpower requirement in the Department. To be Responsible for achieve the shift KPI factors such as, Labour Productivity, Optimum utilization of Consumables, progress of improvement projects, RTY, stocks, etc., are closely monitored. To consistently achieve and maintain optimum levels in the prescribed and established quality standards in the manufacturing process and as a practice keep the scrap and wastage as per prescribed and established norms and Endeavor to constantly improve the quality further. To supervise timely delivery of processed materials to other departments for further process of the final product and thus avoid zero idle time in department and Endeavor to achieve optimum productivity. To focus on achieving the Quality, EMS and Health & Safety objectives applicable to the department. Prepare and submit the Shift / Daily reports. To maintain efficient workplace by practicing 1S. To identify non-conformances and implement corrective and preventive actions as per the procedure. To ensure that all Operators are trained in consultation with the Human Resource Department to achieve the required skill level and acquire as many multi-skills as possible and become proficient in eliminating losses. To disseminate the overall knowledge with the respect to the established process and systems for the Department across all the subordinates. To consistently counsel and motivate the subordinates in such a way that their motivational and morale levels are always high and inculcate positive discipline. To take counter measures to eliminate accidents due to unsafe conditions / acts, near miss that have been identified in the Department. To ensure calibration and validation of the equipment that are used in the Department are carried out as per the requirements for the process. Maintain Safe & Healthy work environment including safety of people, assets & properties of the company. Reporting of EHS activities /concerns /incidents /near miss and accidents. Ensure no injuries at workplace. To ensure that there is no adverse impact on the environment due to the activities of the department. To ensure compliance of GMP, SOPs and other systems / procedures of the company. To ensure that the requirements of ISO 9001, USFDA QSR-CFR Part 820, ISO 13485, ISO 14001 and such other international standards are maintained. This job description is subject to change by the Management to suit changing requirements from time to time. Such other assignments the management may give from time to time, including orientation to Project Teams / Sub-Committees. To ensure that ERP system is properly followed in the department in a timely manner and to ensure data accuracy. Comply with and monitor work practices are according to Lifestyles values and Ethical Business Conduct Policy. About the Company LifeStyles has a history dating back to 1905 when Eric Ansell first started making condoms in Richmond Australia. Today LifeStyles is a Global leader in the sexual wellness sector, comprising a broad range of condoms, personal lubricants, and other related products and other products in over 60 countries. Owning a large portfolio of trademarks, LifeStyles manufactures and commercialises its products either under leading global non-latex condom brands SKYN under its local heroes such as LifeStyles, Manix, Unimil, and Blowtex and Control. Outside of branded products, the Company also supports universities, NGOs, and other organizations as part of a broader effort to promote sexual health and prevent the spread of STDs and STIs. LifeStyles owns and operates manufacturing facilities in Thailand, India and Spain, and it employs over 1,600 teammates globally. LifeStyles Healthcare was created on September 1, 2017 , when the consortium of Humanwell Healthcare & CITIC Capital private equity purchased the Sexual Wellness division from Ansell. As of December 1, 2022, Lifestyles is owned by Linden Capital Partners , a Chicago-based private equity firm focused on the healthcare industry. This is an exciting time to join us. We combine century-long history with the opportunity of a new beginning as a stand-alone company - this means a new way of thinking, the opportunity to explore new horizons and the chance to make a mark in an exciting, fresh business. LifeStyles Healthcare is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We are empowered professionals, and we are committed to creating a team of the worlds best of the best. Our business foundation is strong, among our values are Integrity and Respect, our people are highly engaged, and we are excited about a new phase in the company history. We have a focus on safety and teamwork - and we want you to join us! All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Discover more about us at: https://www.linkedin.com/company/lifestyles-healthcare/. Curious to know what does every day look like at LifeStyles Find out by looking at employee testimonials: https://lifestylesglobal.com/careers Due to the high number of applications, we would like to inform you that only selected candidates will be contacted. Show more Show less

What you will do Independently processing results of PFA assessments. Initiate, organize and coordinate global containment actions Ensure that data is documented for the different sites. Together with the PFA specialist create a communication to affected parties. Provide necessary information to regulatory compliance team for reporting. Presenting PFA/commercial hold relevant processes and cases during audits Preparing weekly, monthly and quarterly Commercial Hold relevant statistics Performing training of colleagues and managers by procedural changes What you need Required Skills: B. Tech / M.Tech Mechanical, Biotechnology with hands on experience of working on PFAs, and Commercial Holds. Hands on experience of problem-solving methodology and root cause analysis, 7 QC tools, Problem Solving & CAPA, Strong Analytical ability. Poses the ability to lead colleagues in other departments to perform the necessary actions for a timely Containment action Hands on experience of Risk Management process as per ISO 14971 Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies. Sound knowledge on complaint handling process of medical devices will be an added advantage Applied understanding of GDP, ISO 9001 & ISO 13485 (Good to have).Good understanding of FDA 21CFR Part 822 / 820 (Good to have) Preferred Skills: Demonstrated ability to self-motivate, ability to prioritize tasks in a deadline-driven environment. Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams. Travel Percentage: 20%

Job Description Summary In this role you will develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. You will ensure that projects and products are capable and will meet specified standards (Preventive). You will have In-depth understanding of key business drivers; uses this understanding to accomplish own work. You will ensure each project is developed & released meeting customer expectations and regulatory requirements . GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description Roles and Responsibilities Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms. Supports continuous product and process improvement through detailed failure analysis for nonconformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program). Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy. A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations. Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance. Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions. Required Qualifications This role requires advance experience in ISO 13485 and SDLC 62304 domain in a regulated industry (such as FDA, EUMDD/MDR Demonstrated knowledge on cybersecurity and privacy regulations. Knowledge level is comparable to a Bachelors degree from an accredited university or college ( or a high school diploma with relevant experience). Minimum Years of experience in the relevant industry - 5 to 10 Years or more Desired Characteristics Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to ISO 13485 and FDA 21 CFR 820. Inclusion and Diversity We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you d expect from an organization with global strength and scale, and you ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. Relocation Assistance Provided: No

Job Description Summary In this role you will develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. You will ensure that projects and products are capable and will meet specified standards (Preventive). You will have In-depth understanding of key business drivers; uses this understanding to accomplish own work. You will ensure each project is developed & released meeting customer expectations and regulatory requirements . GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description Roles and Responsibilities Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms. Supports continuous product and process improvement through detailed failure analysis for nonconformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program). Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy. A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations. Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance. Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions. Required Qualifications This role requires advance experience in ISO 13485 and SDLC 62304 domain in a regulated industry (such as FDA, EUMDD/MDR) Demonstrated knowledge of Cybersecurity and Privacy. Knowledge level is comparable to a Bachelors degree from an accredited university or college ( or a high school diploma with relevant experience). Minimum Years of experience in the relevant industry - 5 to 10 Years or more Desired Characteristics Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to ISO 13485 and FDA 21 CFR 820. Inclusion and Diversity We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you d expect from an organization with global strength and scale, and you ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. Relocation Assistance Provided: No

Position: Manufacturing Process Engineer Reporting to: Quality Manager Location: Pillaipakkam (Factory) Summary: As a process engineer, you will analyse and optimize manufacturing and industrial processes to improve efficiency and reduce costs. This includes process designing, troubleshooting, process optimization, process analysis, process documentation, quality control, project management, process automation and quality assurance. You will also collaborate with cross-functional teams, implement process improvement initiatives and contribute to the overall success of our organization. Roles responsibilities: 1.Conduct detailed process evaluations and gap analyses to identify areas for improvement in existing manufacturing operations. 2.Design and implement process optimization strategies to improve efficiency, reduce cycle times, and enhance product quality. 3.Collaborate with Engineering, Production, and Quality teams to develop and maintain Standard Operating Procedures (SOPs) and Work Instructions. 4.Monitor key process performance indicators (KPIs) such as cycle time, yield, scrap rate, and Overall Equipment Effectiveness (OEE) to meet or exceed operational targets. 5.Establish and maintain process control measures, including Statistical Process Control (SPC) techniques, to reduce variability and ensure consistent product quality. 6.Provide technical troubleshooting support to resolve process-related issues and improve equipment performance. 7.Lead process validation activities, including protocol development, execution, and documentation in compliance with regulatory standards (ISO 13485, 21 CFR Part 820). 8. Participate in root cause analysis, corrective action, and preventive action (CAPA) initiatives for process deviations and product quality issues. 9.Deliver training and provide guidance to production teams on new processes, procedures, and equipment to ensure successful implementation. 10.Stay current with advancements in process engineering, lean manufacturing, and automation technologies to continuously improve production capabilities. Required Skills and Qualifications: i. Bachelors degree in Mechanical, Plastics, Metallurgical, Process Engineering. ii.2-3 years of experience as a Process Engineer in a manufacturing environment, preferably in medical device or medical product manufacturing. iii. Strong knowledge of process optimization, lean manufacturing, Six Sigma, and statistical analysis. iv Proficiency in process modeling, data analysis, SPC, and process simulation software. v. Excellent problem-solving and analytical skills with the ability to manage complex process challenges. vi. Working knowledge of process safety, risk assessment, and regulatory compliance (ISO 13485, ISO 14971, FDA 21 CFR Part 820). vii. Effective communication and interpersonal skills for cross-functional collaboration. Strong project management abilities with proven capability to manage multiple priorities and deliver within deadlines. Preferred candidate profile Bachelors degree in mechanical, plastics, Process engineering, knows the regulatory compliance

Skills: Ensure QMS compliance with ISO 13485:2016, ZED, and GMP standards. Review and approve batch records, SOPs, and quality documents. Oversee product packaging, labeling, testing, and release for dispatch. Investigate and manage deviations, complaints, CAPAs, and change controls. Monitor warehouse conditions, equipment calibrations, and validation records. Coordinate internal/external audits, inspections, and supplier evaluations. Ensure timely product testing and maintain ETO batch records. Conduct training sessions on quality procedures as per schedule. Prepare Certificates of Analysis and assist in regulatory certifications. Coordinate with cross-functional teams for QMS adherence and documentation.Must be B-pharma/ M- pharma, Medical Device.

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. Responsibilities may include the following and other duties may be assigned: 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 analyis, Post market surveillance, Design Controls for Medical Devices. Required Knowledge and Experience 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. 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. 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. 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

A Day in the Life A Day in the Life The Software Test Engineer will focus on supporting medical device software testing. The position is a hands-on test development & individual contributor role with a dynamic set of responsibilities in a complex software system including test design & development, design of test automation framework, test scripts development and test execution. Responsibilities may include the following and other duties may be assigned Test execution and document software using manual and/or automation methodologies. Thoughtfully develop testing strategies and protocols with state-of-the-art software best practices. Develop test strategies, review test designs, and validate test scripts, verification of software. Provide support for NPTV (Non-product tool validation). Navigate the complexities of industry and government regulations to include IEC62304, IEC82304 and FDA QSR (Quality System Regulation) requirements. Develop, document, and test software to ensure that the software meets the needs of end-users and achieves business goals. Provide assistance to development teams. Commitment to achieving and exceeding project goals and timelines. Thrives in working with other disciplines to develop system-minded implementations that consider safety, performance, communication, user interface and other aspects of a final Medical Device product. Work in a cross-functional Agile team across global R&D teams to test software for new and existing medical device products. Participate in reviews of requirements, design, implement and test to ensure quality standards are met. Analyze unexpected, undesirable, or non-understood behavior in software and in interactions of software with hardware. Document results of defect analysis. Follow the IEC 62304 standard and project documents such as the software development plan and coding standards. Participates in other quality assurance functions, including, but not limited to, static code analysis, risk/hazard analysis, and test automation development. Should be an excellent team player with good communication skills. Should meet key business KPI/project metrices. Required knowledge and Experience A Bachelor s degree in Computer science, Electrical, Electronics / equivalent from reputed institution. 4 to 8 years experience in Software verification & Validation with at least two (2) years experience in the Medical device/Medical IT or regulated industry. Experience in test automation preferably using Java, Groovy, Selenium, Appium. Experience on both white box and black box testing and strong debugging skills. Experience in hardware/software interfacing and design issues. Participate in System design, coordination with teams and internal product management. Experience with software risk analysis (per ISO 14971) including software failure mode and effects analysis (FMEA). Awareness of Medical Device standards IEC 60601-1, IEC 62304, ISO 13485, ISO 14971, and applicable FDA standards Excellent debugging skills and problem-solving capabilities Experience working in a structured software development environment following a well-defined software development process like Agile / Lean. Must be a great individual contributor and team player. Must have qualities including being positive, high standards, resilient, open, and creative. Appreciation of discipline and work required to develop software in a regulated industry 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). 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

Career Category Quality Job Description Let s do this. Let s change the world. In this vital role you will act as the Quality Engineering representative on multi-functional teams, employ quality principles and company s procedures including but not limited to the areas of device design control, Change Control and NC/CAPA, Risk Management, Human Factors Engineering, to ensure development and lifecycle management of final product align with dynamic global regulations and standards. The Sr Quality Engineer will be an integral part of the design and development of combination products, providing quality oversight of the processes and deliverables generated throughout development and commercialization. In addition, this role will also support various aspects of the product lifecycle including complaint investigations, expansion and transfer of products to new manufacturing sites, inspection readiness activities, and platform support and improvements. Responsibilities: Provide Quality technical expertise, Quality oversight, and serve as a single point of Quality contact for combination and non-combination products associated with final product activities. Ensure program alignment and proper linkages within the Design and Development Plans, Risk Management Documentation, and Control Plans. Provide oversight and review of Human Factors Engineering (HFE) Protocols and Reports, as well as onboarding and auditing HFE suppliers related to life cycle management of commercial programs. Train and educate key functional partners and management on combination product requirements, standards and regulations Contribute to content and review of regulatory submissions and RTQs, and support audits and inspections for associated projects related to life cycle management of final product programs Scope may include a wide range of products, including but not limited to vial, prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, electromechanical on-body injector systems, and accessories. Plan and lead continuous improvements to the quality processes related to devices, combination product, assembly, labeling and packaging. Provide independent design review for other programs Provides quality oversight of the development, qualification, validation, transfer and maintenance of physical test methods including sample selection NOTE: This role may require working in shifts or extended hours within the same shift What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a with these qualifications. Basic Qualifications: Doctorate degree OR Master s degree and 4 to 6 years of Quality experience OR Bachelor s degree and 6 to 8 years of Quality experience OR Diploma and 10 to 12 years of Quality experience Preferred Qualifications: 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry (device experience a plus) Bachelor s Degree in a Science Field Ability to oversee multiple medium complexity projects simultaneously Working knowledge of quality engineering and/or mechanical engineering Familiar with final products including applicable guidance, regulations and standards (e.g., MDR, ISO 14971, ICH Q9, ICH Q8, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211) Prior experience working as part of a combination product launch team Able to successfully manage workload to meet timelines Ability to effectively negotiate, articulate, and defend a position after taking feedback from multiple sources Ability to operate in a matrixed or team environment with site, functional, and executive leadership Experience driving decision making by using Decision, Advice and Inform (DAI) principles Understanding of industry requirements/expectations of a Quality Management System (QMS) Understanding of the applicable manufacturing/testing processes (i.e. Active Pharmaceutical Ingredient, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Execution of technical standards, internal requirements, and regulations Comfortable with both drug and device terminology Ability to travel +/- 15-20% of time to domestic and international Amgen sites What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Manage Change Notices in Windchill PLM, handle QMS docs and CAD files, process ECNs/ECRs, ensure ISO 13485 compliance, support QMS improvements, and collaborate globally for timely and accurate documentation Required Candidate profile This is for quality management document control.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Gurgaon, Haryana, India Job Description: Required Qualification and Core Competencies for the role: 8-12 years of experience in regulatory affairs in medical device industry. Strong knowledge of Medical Device Rule 2017 Strong knowledge of Drugs and Cosmetics Act Knowledge in the international regulations of Medical Devices in US and EU Sound knowledge on Medical Device Quality Management System ISO 13485 Excellent proficiency with software tools Key responsibilities: Draft, review and submission of Regulatory filings (Re-registrations/ New Registrations/ Legal-Physical manufacturer transfer). Draft, review and submission of other Regulatory submissions (Query responses, Corrections fillings, miscellaneous notifications regarding post registration regulatory lifecycle management) for India and IB market in accordance with applicable regulations and relevant guidelines. Draft cover letters for Regulatory communications/ submissions depending on level of regulatory knowledge/expertise Update and live maintenance of business plan in SharePoint for assigned franchises/ licenses. Assist in the preparation of technical presentations/ meetings with regulator Ensures compliance with regulatory agency regulations and interpretations. Gathers and assembles information, prepares documents for New Product Applications/Renewal Applications/Change Notifications/Response to Regulatory Agencies questions in accordance with regulations and relevant guidelines Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations (Lifecycle management) Coordination with internal stakeholders ensuring compliant lifecycle management of responsible products/ franchises. Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations Attend applicable training sessions as well as complete mandatory on-line e University trainings and submit training records to the supervisor / Admin assistant and work as per the applicable SOPs and guidelines. Maintenance of RA database for the responsible franchises in MDRIM tool. Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA team through email/other portals. Ensuring timely completion of assigned Quality issues/ Corrective Actions in ETS system. Creation and maintenance of Product Registrations request Form (PRRF) for any registration activities under responsible franchises/ licenses and Change Controls for any product discontinuation/ changes as per defined procedure. Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA team through email/ other portal. Ensure on time archival of regulatory submission documents. Supporting Pharmacovigilance and artwork activities for biological products (if applicable) Control of regulated/ non-regulated products/ codes in RA gateway tool. Support with on-time inputs for monthly regulatory report. Participate in execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner Understand complaint & adverse event reporting responsibility and report such events within 24 hours of becoming aware. Conducting Regulatory Standard Management monthly meeting and keeping a track on action items identified.

A Day in the Life Be a part of the Medtronic Engineering and Innovation center (MEIC) by applying your skills to the growth and development & sustaining efforts of Medical Devices products at MEIC. As a member of the MEIC team, you will collaborate with the broader Medical Devices engineering team, clinical and commercial teams globally. You will enable design & development of medical devices/products and the associated infrastructure & capability building elements in close conjunction with the Global teams. Responsibilities may include the following and other duties may be assigned Experience in distributed product development, team building skills, talent management, conflict resolution, budget management and global stake holder management are critical to the role. Manage a cross functional (SW, FW, HW, Systems) engineering technical team size of 20 or more. Provide a blend of people management and technical savviness. Should have worked on development of products and on successful delivery of solutions. Deep understanding in product development processes & regulations (IEC 60601, IEC 62304, ISO 13485, ISO 14971) Design controls for medical device development in order to coach and guide the technical leads is expected. Identify the needs and prepare capabilities in the cross functional areas, SW development and verification and validation areas to foster full turnkey solution to the business. Provide a deep understanding of the embedded and application SW development processes (Agile, waterfall methodology) and help establish SW metrics & recommended the processes for the team. Research and maintain solution architecture, technical design, tools and technology stack and related system and drive proof of concept efforts in MEIC. Must be able to support the global team in organic, blended, inorganic product development projects. Support the technology road map of Medical Devices by proactively pitching for technology development and turnkey projects. Support Regional Growth plans and product requirements to boost tailored product for the regions Establish and remain educated on the relevant technology standards (DICOM, HL7, 62304, ISO 11073 etc. ) Develop junior members by coaching, empowering, reviewing results, both in technical areas and in soft skills. Identify solution knowledge gaps within MEIC in Medical Devices solutions and prepare plans to address them ( strategic alliances and self-managed teams ) The incumbent would work with the project management office at MEIC to ensure that resource forecasts, project metrics are correctly captured and presented to the leadership Frequent interaction with team members from other disciplines, cross functional teams, to understand project requirements and to adhere to project schedules. Possible interaction with clinicians, third-party vendors, manufacturers, and subcontractors. Required Knowledge and Experience Good hands on experience in Linux-based development environments with strong proficiency in C, C++, or Rust. Skilled in contributing to end-to-end software solutions. Knowledgeable in design controls for medical devices (related to CFR 820. 30) 510K, IEC 62304 & other relevant standards. Product development experience for local markets ( in country for country) would certainly be a plus. Strong proven capability & track record in developing product applications and strong knowledge in device communication & diagnostics, database systems and latest communication protocols. Hands-on application development (right from requirement analysis to deployment) and management of sizeable teams in FW, HW, & SW application development & verification activities. Strong Leadership expectations traits for mid-level leaders (internal candidates only) Bachelor s or Master s degree either in Computer Science, Computer Engineering or Electronics & communication Engineering. 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. 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

Job Summary: Responsible for managing day-to-day operations of the calibration lab, maintaining documentation, ensuring compliance with ISO/IEC 17025 and regulatory requirements, and overseeing calibration activities for thermal and biomedical devices. Acts as the coordinator equipment traceability, and calibration data management. Key Responsibilities: Maintain and control all calibration-related documents such as SOPs, calibration procedures, master equipment records, and logbooks. Review calibration results and ensure correctness before issuing certificates. Monitor the validity and performance of master equipment and arrange for their periodic calibration. Maintain equipment history cards and calibration status labelling Ensure compliance with ISO/IEC 17025, ISO 13485, and NABL documentation requirements. Manage environmental monitoring records (temperature, humidity) for thermal calibration setups. Qualifications and Skills: Experience in NABL Lab [Calibration discipline- Medical devices, Thermal etc, QA Testing]. Understanding ISO/IEC 17025. Preferably a person with thermal training certificate. Minimum 2-3 years of experience in calibration lab with exposure to medical and thermal disciplines. Document Control & Record Keeping, Verifying the calibration & QA report, Excel techniques etc. No. of positions: 1

Job Summary: Seeking a detail-oriented and proactive Field Auditor to evaluate and ensure compliance of service activities and office operations with company standards and regulatory requirements. The Field Auditor will be responsible for conducting on-site audits at hospitals and office locations, reviewing service engineer performance, inspecting documentation, identifying non-conformity, and recommending corrective actions for continuous improvement. Key Responsibilities: Conduct field audits of service engineers at hospital sites to verify adherence to service protocols, safety standards, and documentation practices. Audit office operations including documentation control, inventory management, complaint handling, and coordination processes. Review maintenance records, calibration certificates, and service reports for accuracy and completeness. Identify gaps, risks, or non-compliance and prepare audit reports with actionable recommendations. Follow up on corrective and preventive actions to ensure closure of non-conformity. Liaise with Quality Assurance, Technical, and Customer Service teams to support overall compliance and performance improvement. Qualifications and Skills: Minimum 3-4 Years experience in Field Auditing. Auditor certifications on ISO standards like ISO 13485 / ISO 9001 etc-preferred Engineering degree in Biomedical. Excellent observational, analytical, report-writing and M S excel skills. Languages - Hindi, English, Regional Language. No of positions: 1

Seeking an experienced RPA (Robotic Process Automation) Developer to join our team. As a developer, you will be responsible for in working in a project team in developing, testing and the processes as per client needs. Qualifications and Experience: Skills Required: Design, Develop and test: Development of RPA processes using any of the RPA tools, test the processes and deploy to production. Proven experience of 2+ years as an RPA Developer and implementing RPA solutions. Knowledge or experience in creating frameworks, modifying, and maintaining. In-depth knowledge and experience on RPA tools such as UiPath, Automation Anywhere, or Blue Prism(any 1 tool) Working with Orchestrator and Control Room, configuring machines, bots, and other areas is an added advantage. Experience on QA processes. Excellent problem-solving and analytical skills Strong communication skills Certification in one RPA tool (UiPath, Automation Anywhere, or Blue Prism) is mandatory.

Senior Test Engineer As a Test Engineer / Senior Test Engineer, you will be responsible for designing, implementing, and maintaining automated systems. Your role will be critical to enhancing and upholding highest standards of efficiency, quality, and reliability of high-impact systems and applications of our industry-leading clients including Fortune 500 enterprises. You will work on various mission-critical automation projects and collaborate with cross-functional teams to integrate automation technologies successfully across the organization. Key Responsibilities: Develop test plans to ensure automated systems meet performance, safety, and functionality standards. Execute automated tests, validate results, and make necessary adjustments to improve the systems. Provide ongoing support and maintenance for automation systems, ensuring minimal downtime. Troubleshoot and resolve issues with automation systems to maintain system reliability. Develop and implement automation scripts for testing across various frameworks and technologies. Deep expertise in Java Selenium / C# Selenium / Python. Understanding of integrations with multiple tools across the testing ecosystem. Collaboration with cross-functional teams for smooth integration of automation technologies. Engage in client interactions to understand requirements and provide updates on testing progress. Qualifications and Experience:

Experience 5-10 Years Job Type Full Time Key Responsibilities: Engaging with prospects through Emails / LinkedIn and other channels to generate interest in QualiZeal s service offerings. Research, identify, and segment prospects based on company profiles and LinkedIn data Qualifying prospects based on their Industry / Revenue / Geography Adding new companies/contacts in the assigned territory leveraging appropriate tools (LinkedIn, ZoomInfo, and others) Maintaining a database of prospects with proper hygiene. Managing outreach campaigns with a focus on deliverables and outcomes. Follow up with prospects in a timely manner and set up meetings for sales folks to pitch to Timing is key Qualifications and Experience: Years Of Experience: 5 to 10 years Educational Qualification: Any Graduate, Postgraduate. Skills Required: Minimum 3 years experience. Proven track record of exceeding targets. MBA in Marketing preferred Excellent written and communication skills Good understanding of professional standards in writing and formal communication in the NA markets Extensive experience in research tools like LinkedIn / ZoomInfo / Crunchbase etc. Ability to adapt quickly to changes (in markets, strategy, etc.)

Experience 20+ Years Job Type Full Time Key Responsibilities: Strategic Leadership: Shape and execute the strategic vision for Quality Engineering and Testing Services across BFSI, Retail, and Energy & Utilities. Lead high-performing teams to deliver innovative, client-focused solutions. Drive thought leadership through the adoption of modern QE practices, automation, and AI technologies. Operational Excellence: Oversee end-to-end delivery of testing services to ensure high-quality, on-time outcomes. Establish and track KPIs to monitor performance, productivity, and client satisfaction. Streamline operational processes to enhance efficiency and scalability across global teams. Domain Expertise: Provide guidance on QE best practices with a focus on industry-specific needs. Continuously monitor trends in AI, automation, and testing to evolve service offerings. Transformation & Innovation: Champion digital transformation by integrating emerging technologies and methodologies. Lead innovation initiatives across the testing lifecycle to drive continuous delivery and automation. People Leadership & Development: Mentor senior leaders and teams, promoting a culture of excellence and growth. Develop leadership programs, succession plans, and talent retention strategies. Client Relationship Management: Build strong relationships with key clients, aligning QE solutions with their business goals. Partner with sales and business development teams to drive growth through new and existing accounts. Qualifications and Experience: Years Of Experience: 20+ years Technical Skills: Technology Leadership: Proven expertise in QE, automation, and AI applications in testing. Domain Knowledge: Deep experience in Insurance, Retail, or Energy & Utilities, with an understanding of industry-specific challenges. People Management & Leadership: Track record of mentoring and leading diverse global teams with a servant-leadership mindset. Transformation Expertise: Experience driving tech-led organizational change and modernizing QE practices. Client-Centric Focus: Ability to engage C-suite clients, translating business challenges into actionable solutions. Communication & Stakeholder Management: Exceptional collaboration and communication skills across geographies and functions. Business Acumen: Strong P&L understanding with a focus on aligning QE services to measurable business outcomes.

Job Title Software Quality Engineer Job Description Job title: Software Quality Engineer Your role: Ensures that appropriate SW Quality plans are made that include all stages of the software life cycle and supports SW Quality Plan design. Validates key design inputs (i. e. usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs). Provides effective oversight of the execution of the SW Quality Plan and any Risk Management activities, and of all design related activities during the software lifecycle. Can lead quality related problem solving for software. Use post-market analytics and statistics to report on software performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiate field actions as necessary, as required. Act as a business partner, single point of contact (person assigned to project team) responsible to ensure that software design quality related requirements/criteria are completed and meet SW Quality standards for every milestone. Youre the right fit if: (4 x bullets max) 1. Experience- 10+ years of industry experience in PQE 2. Skills: Worked in medical industry product development team (exp of 3 to 8 years) as QE. SW domain is must. Strong knowledge in QMS 13485, 21 CFR, EU MDR, SW LC 62304, Usability 62366, RMM 14971 and experience in guided R&D team. Heavily involved in all design control doc reviews and maintained DHF. Guided R&D team for Defects Handling and tracked defects. Experience in handled internal & External audits Prepared QMS procedures and Templates are additional advantage. Good knowledge in CAPA, Regulatory, Verification and Post Market Surveillance. 3. Education- Candidate shall be with B Tech in Computer Science (or) experience as SW Developer 4. Anything else- Must following one the skills ISO 13485 - Quality management systems for Medical Devices IEC 62304 - Medical device software Software life cycle processes ISO 14971 - Application of risk management to medical devices IEC 82304 - Health software, Product Safety IEC 62366-1 - Application of usability engineering to medical devices EUMDR European Medical Device Regulation 21CFR US FDA Medical Regulation 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 company s facilities. Field roles are most effectively done outside of the company s main facilities, generally at the customers or suppliers 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 wont 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. Learn more about our business . Discover our rich and exciting history . Learn more about our purpose .

Job Purpose : (what contribution is this position supposed to make in business?) The QMS and EU MDR Compliance Executive is responsible for ensuring compliance with ISO 13485, EU MDR (Regulation EU 2017/745), and other applicable quality and regulatory requirements. This role will support the development, implementation, and maintenance of the Quality Management System (QMS), oversee documentation control, conduct internal audits, and support regulatory submissions and audits as required. Key Deliverables/Responsibilities of this position 1- Quality Management System (QMS): Maintain and improve the ISO 9001:2015 / ISO 13485:2016-compliant Quality Management System. Ensure effective implementation of quality procedures and policies. Manage document control, change control, CAPA, non-conformances, and risk management processes. Coordinate internal audits, supplier audits, and management reviews. Monitor key quality metrics and report quality performance. 2- EU MDR Compliance: Ensure ongoing compliance with EU Medical Device Regulation (EU MDR 2017/745). Support the preparation and maintenance of technical documentation in accordance with Annex II and III of EU MDR. Work with cross-functional teams to ensure products meet General Safety and Performance Requirements (GSPRs). Coordinate with Notified Bodies during audits and technical file reviews. Support UDI, PMS (Post-Market Surveillance), and vigilance processes under EU MDR. 3- Regulatory Affairs: Assist with regulatory submissions and CE marking activities. Maintain up-to-date knowledge of applicable regulatory requirements and changes. Liaise with regulatory consultants, Notified Bodies, and competent authorities as needed. 4- Assist in compilation of technical files & related documentation: • Preclinical studies • Usability engineering as per EN 62366 • Risk management reports – as per 14971 • Clinical evaluation reports – as per MEDDEV 2.7.1 5- Knowledge of EU Regulation (EU) 2017/745, to prepare & compile: • Post Market Clinical Follow up (PMCF) • It is the requirement of EU MDR, Annex XIV • PMCF shall be understood to be a continuous process that updates the clinical evaluation • Post Market Surveillance (PMS) • It is the requirement of EU MDR • Labelling requirements • It Is related to Labeling requirements of medical devices as per EU MDR. Means candidate must understand the related requirements & standard knowledge. • UDI requirement. • It Is also related to Labeling requirements of medical devices as per EU MDR. UDI is the new requirement which must be present in CE certified product labels. • Unique device Identification. 6- Preparation and amendments of quality system procedures 7- Assist in external audits & internal audits 8- Knowledge of Quality Control Operations & Problem Solving & Continuous Improvement Required Technical Skills: Knowledge of ISO 13485 & Regulation (EU) 2017/745 Required Behavioural Attributes: Good learner Interactive with team Good communication skills

Job Summary Product Quality supports and collaborates with the Engineering group and Cross Functional teams to enable a diverse range of product releases in an efficient and compliant way. This role is focused on Strategy & Delivery Excellence - enabling velocity of product releases in alignment with established strategies, while also providing expertise to inform new strategies and improve design control processes, systems and tools. Let s talk about Responsibilities Author and communicate the project QA plan to enable new product implementation or changes to released product in an efficient way that satisfies ResMed s Quality System, regulatory requirements (e.g. ISO13485, CFR820, MDSAP), risk and project timing. Apply balance of risk, regulatory intent and business needs to come to efficient and effective solutions. Define these strategies by close collaboration with stakeholders, considering benefit-risk, consistency across projects and starting with a yes mindset. Regularly attend product cross functional team (XFT) meetings and actively participate in a positive, value-add manner. Review Product Development deliverables to ensure they are completed accurately and efficiently. Conduct ongoing compliance reviews and provide reports as requested. Approve product releases based on successful completion of deliverables and compliance reviews. Advocate customer expectations for product quality and reliability, by providing effective, targeted and timely input to decisions. Also identify, evaluate and escalate risks during development that could impact product quality/reliability/field performance. Effectively communicate these concerns and lead or participate in resolution of product quality/reliability risks with the XFT, QA, RA and other stakeholders. Actively engage, collaborate and build relationships with global stakeholders and leaders, including Engineering, QA, RA and other cross functional partners to understand business/department needs, risks and concerns. Build this consideration into strategy planning and proposals to close gaps in an efficient, technical, and compliant manner Identify areas and opportunities to improve QMS processes Participate and lead support of internal and external audits within the relevant areas. Participate in relevant investigations as relate to design controls and ensure CAPA findings, risks, recommendations and outcomes are appropriate and are clearly documented and communicated. To support projects across hardware & digital portfolios including but not limited to projects like NPI devices, SaMD, AI/ML models, Platform, IoT projects etc. Let s talk about Qualifications and Experience Required (Qualifications/experiences that are an absolute must for the position) Degree in Engineering, Computer Science, Science or other tertiary qualifications deemed appropriate for this position. Strong understanding of MDSAP, FDA, MDD/MDR and ISO Quality standards/regulations, including ISO13485, ISO14971 and IEC62304 for software development. e.g. Agile, DevOps. Maintain knowledge of current good design practice for hardware and software in both medical and adjacent industries. Experience within product development environment

Role & responsibilities Architect and implement a lean, auditready ISO13485:2016 Quality Management System and drive certification. Own all designcontrol documentation (SRS, DHF, Risk Management File, DMR, Technical File, etc.) in collaboration with engineering teams. Define and execute regulatory strategies: first CDSCO (ClassII/III), then FDA 510(k), and EU MDR CE Mark. Prepare, review, and submit regulatory dossiers; interact with authorities and notified bodies. Plan and conduct internal audits, manage CAPA investigations, and lead continuousimprovement initiatives. Qualify and monitor suppliers/CMOs; establish incoming and inprocess quality controls and batchrelease records. Train crossfunctional teams on standards, good documentation practices, and change control. Set up postmarket surveillance, complaint handling, and vigilance procedures ahead of launch. Preferred candidate profile Bachelors degree in engineering, Life Sciences, or related field; ISO13485 internalauditor certification preferred. 5 –10years’ QARA experience with ClassII (or higher) medical devices, ideally in a startup/smallteam environment. Demonstrated handson implementation of ISO13485 and compilation of CDSCO dossiers or FDA/CE submissions. Working knowledge of ISO14971, IEC62304, IEC60601, and Indian MDR2017; familiarity with EU MDR and 510(k) processes. Strong documentation skills, analytical mindset, and ability to translate regulatory language into actionable tasks for engineers. Selfstarter who thrives with minimal supervision and juggles multiple priorities in a fastmoving startup.

Required Qualifications: Bachelors or master’s degree in mechanical, electrical, or Systems Engineering , or a related technical field. 3+ years of experience in V&V for medical devices , ideally with complex systems involving fluidics, embedded systems, or renal therapy technologies . Hands-on experience designing and executing verification tests for software-controlled electromechanical systems. Strong knowledge of systems engineering principles , including the V-model , requirement validation, and test traceability. Proficient in using lab instrumentation (e.g., flow meters, pressure sensors, data acquisition systems).

Additional Locations: India-Haryana, Gurgaon Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing - whatever your ambitions. Key Responsibilities: Read and interpret technical drawings, procedures, and protocols. Import and maintains the project documentation in online RM tool throughout all phases of NPD and Sustaining. Investigates and evaluates the compliance requirements driven from organization s QMS/Work Instructions and validate the same in templates developed in RM tool. Investigates and evaluates existing RM tools/technologies - JAMA, Polarion, Cockpit etc. Investigates compliance gaps in project documents and resolve them with project stake holders. Collaborate with cross-functional process, method, and teams to understand and implement solutions to resolve compliance gap issues in documents. Performs validation of patches and versions of RM tool as and when available. Support multiple projects across different time zones - Asia, Ireland, and North America Qualifications Required: Mechanical Engineering ( B.E./B.Tech) with 4-5 years of experience Preferred experience in management of DHF documentation during full life cycle of medical device as per ISO 13485, and ISO 14971 Preferred experience in RM tools like JAMA, Polarion, DOORS, Cockpit Knowledge of MS Office Tools - Word, Excel, PowerPoint. Strong attention to detail with good communication skills. Strong strategic / analytical thinking and problem-solving abilities, with a data-driven approach to decision-making. Ability to collaborate and work as a team player. Nice to have experience in product lifecycle management software and tools. Willingness to work in an agile environment. Requisition ID: 610104 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn t just business, it s personal. And if you re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!