New Product Verification and Compliance Manager
Must Haves
· BSc in Engineering with strong background in electronics
· 8 years of progressive V&V management responsibility with at least 4 years in the medical device industry, or equivalent work experience and/or professional qualifications
· Working knowledge of, and auditing experience to, the FDA Quality System Regulation, ISO 13485, IEC 62304, and the EU Medical Device Regulation.
· Experienced in product risk management to the requirements of ISO 14971.
· Skilled in statistical methods, statistical process control and sampling plans
· Familiar with reliability analysis and test methods
· Working knowledge of IEC 62304
Your Answer
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About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.
We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.
Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the
future.
Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.
PHYSICAL REQUIREMENTS
