As a Sr. Quality Engineer - PSUR (Periodic Safety Update Report) at Medtronic, you will be instrumental in ensuring the post-market safety and compliance of our medical devices. Your primary responsibility will be to prepare and compile comprehensive PSURs, independently developing plans and reports based on post-market data. You'll serve as a mentor, collaborate with cross-functional and global teams, and navigate evolving regulatory landscapes, contributing directly to Medtronic's mission of healthcare innovation and patient safety.
A Day in the Life
You will drive Medtronic's commitment to product safety and regulatory excellence by:
- Preparing and compiling product post-market data and findings into comprehensive Periodic Safety Update Reports (PSURs) in compliance with regulatory requirements.
- Independently developing Periodic Safety Update Plans and Reports.
- Serving as a mentor to junior engineers, providing guidance and support in quality engineering practices within the realm of medical devices.
- Collaborating with cross-functional teams to gather and analyze data related to the performance and safety of medical devices.
- Partnering with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities.
- Continuously monitoring and staying updated with evolving safety regulations and guidelines to ensure PSUR compliance.
- Developing templates and training based on quality system regulations, applicable standards, and guidance.
- Independently reviewing all deliverables to ensure compliance with the development process and relevant standards.
- Delivering presentations to the QA organization on the status and issues of assigned projects.
- Delivering training to departments outside of QA.
- Demonstrating the ability to effectively play multiple roles on a cross-functional team, including contributor, subject matter expert, leader, and facilitator.
- Participating in audits when appropriate.
- Collaborating with regulatory affairs teams for the submission of safety reports.
Required Knowledge and Experience
- B.E. or B.Tech in Mechanical/Biomedical Engineering.
- Minimum 5-8 years of quality engineering experience or equivalent, and overall 8-12 years of experience.
- Hands-on experience with EU MDR.
- Hands-on experience on Risk Management and Design Controls for Medical Devices.
- Familiarity with Literature review, PMCF (Post-Market Clinical Follow-up), IMDRF coding, CAPA (Corrective and Preventive Action) and NCMR (Non-Conforming Material Report).
- Familiarity with ISO 13485, ISO 14971, EU MDR, and product-specific industry standards.
- Understanding of post-market surveillance processes and adverse event reporting.
- Knowledge of risk management principles and hazard analysis in the context of medical devices.
- Familiarity with ISO 9001, 21 CFR part 820, 21 CFR part 11, and product-specific industry standards.
- Familiarity with DMAIC or DMADV (DFSS) methodologies.
- Good verbal and written communication skills, including plan/report development.
- Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Regulation.
- Previous experience working in a cross-functional team environment.
Nice to Haves
- ASQ CQE, CQA, CSQE and/or CRE certification.
- ISO 13485 Internal Auditor / Lead Auditor Certification.
- Lean Six Sigma Green Belt or Black Belt.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package. We are committed to our employees, recognizing their contributions and providing a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
About Medtronic
Medtronic leads global healthcare technology, boldly attacking 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, leveraging talent, diverse perspectives, and guts to engineer the extraordinary.
