Base: not specified; bonus/equity: cash-based ince...
Not specified
Iso 14971 risk management leadership
Class 2 or 3 device design verification
Fda 510k and eu mdr submission experience
Integer Holdings Corporation is seeking a Design Assurance Engineer III in Plymouth, MN, to ensure compliance with quality management systems and FDA regulations while actively participating in design projects. The ideal candidate will possess substantial experience in quality engineering, risk management, and regulatory submissions
Job Summary
The role involves leading Risk Management activities per ISO 14971 for Class 2 or 3 medical devices.
Candidates will perform design verification and validation protocols to ensure compliance with FDA and EU MDR regulations.
The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, and 401(k) matching.
Matching Summary
Match Score: 85
Integer Holdings Corporation is seeking a Design Assurance Engineer III in Plymouth, MN, to ensure compliance with quality management systems and FDA regulations while actively participating in design projects. The ideal candidate will possess substantial experience in quality engineering, risk management, and regulatory submissions.
Salary
Base: Not specified; Bonus/Equity: Cash-based incentive program available; Benefits: Comprehensive package with immediate eligibility
Skills & Requirements
Must-have
ISO 14971 Risk Management leadership
Class 2 or 3 device design verification
FDA 510K and EU MDR submission experience
DFMEA and FTA analysis expertise
Gage Repeatability and Reliability studies
Supplier qualification and risk management
Nice-to-have
Lean Sigma tools proficiency
Cross-functional team leadership
Root cause analysis skills
CAPA preparation experience
Key Requirements
Bachelor's in Mechanical Engineering plus 5 years experience
Master's in Mechanical Engineering plus 3 years experience
Authority to work permanently in the U.S.
Work Rights
Must have authority to work permanently in the U.S.