

Principal Design Assurance Engineer/7 months ago
Maple Grove, MN
Overview:
Boston Scientific is currently recruiting for a Design Assurance Principal Engineer in our Maple Grove, MN location. This is an exciting opportunity to participate in the development of single-use devices for use with medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division of BSC. Design Assurance Principal Engineer provides focused quality engineering leadership on new product development design assurance. Design assurance drives the ISO14971 risk management process and the Verification & Validation (V&V) process. This includes quality plans, risk management plans and reports, hazard analysis, product risk management workbook (user FMEA and design FMEA), sampling systems/procedures and statistical techniques, verification protocols/testing/reports, validation protocols/testing/reports. This role will be responsible for ensuring quality and compliance through product development and commercialization.
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