At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Sr Quality Engineer for Cardiac Surgery PSUR roleA Day in the Life
- Prepare and compile product post market data and findings into comprehensive Periodic Safety Update Reports (PSURs) in compliance with regulatory requirements.
- Serving as a mentor to junior engineers, providing guidance and support in quality engineering practices within the realm of medical devices.
Must Have
- 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.
- 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.
- Deliver presentations to the QA organization on status and issues of assigned projects.
- Deliver trainings to departments outside of QA.
- Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator.
- Hands-on experience on EU MDR.
- Previous experience working in a cross-functional team environment.
- Hands-on experience on Risk Management, Design Controls for Medical Devices.
- Participate when appropriate in audits.
- Familiar with ISO 13485, ISO 14971 and EU MDR and product specific industry standards.
- Experience in collaborating with regulatory affairs teams for submission of safety reports.
Minimum Qualification
- B E or B.Tech in Mechanical/Biomedical Engineering
- Minimum 5-8 years of quality engineering experience or equivalence and overall 8-12 years of experience
Key Technical Competencies
- Understanding of post-market surveillance processes and adverse event reporting.
- Knowledge of risk management principles and hazard analysis in the context of medical devices.
- Familiar with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.Familiar 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.
Nice to Haves
- ASQ CQE, CQA, CSQE and/or CRE certification.
- ISO 13485 Internal Auditor / Lead Auditor Cerification
- Lean Six Sigma Green Belt or Black Belt
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here
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