Staff Medical Product Quality & Reliability Engineer

Analog Devices Foundation

Base: $113,190 to $163,905; bonus: discretionary p...
Not specified
Medical device v&v strategy development
Global regulatory compliance fda eu mdr
Advanced reliability analysis fmea weibull
Analog Devices Inc. is seeking a Staff Medical Product Quality & Reliability Engineer to lead the development and implementation of verification and validation strategies for medical devices. The ideal candidate should have extensive experience in regulatory compliance and reliability engineering within the medical device sector

Job Summary

  • The Staff Medical Product Quality & Reliability Engineer provides strategic leadership in developing and implementing verification, validation, and reliability strategies for medical devices.
  • This role ensures compliance with global regulatory requirements including FDA QSR, ISO 13485, and EU MDR while driving audit readiness.
  • The position offers a competitive salary range of $113,190 to $163,905 along with comprehensive benefits including medical, vision, dental, and 401k.

Matching Summary

Match Score: 85

Analog Devices Inc. is seeking a Staff Medical Product Quality & Reliability Engineer to lead the development and implementation of verification and validation strategies for medical devices. The ideal candidate should have extensive experience in regulatory compliance and reliability engineering within the medical device sector.

Salary

Base: $113,190 to $163,905; Bonus: Discretionary performance-based bonus available; Benefits: Medical, vision, dental, 401k, paid vacation, holidays, sick time

Skills & Requirements

Must-have

  • Medical device V&V strategy development
  • Global regulatory compliance FDA EU MDR
  • Advanced reliability analysis FMEA Weibull
  • ISO 13485 ISO 14971 IEC 62304 standards
  • Cross-functional team mentorship and leadership

Nice-to-have

  • Six Sigma Lean certification preferred
  • ASQ CRE certification desirable
  • Model-based systems engineering experience
  • Predictive analytics for reliability trends
  • Automated test system development skills

Key Requirements

  • Bachelor's degree in Engineering or Life Sciences
  • Master's degree preferred
  • 5+ years experience in medical device V&V and reliability
  • Expert knowledge of FDA QSR and ISO standards
  • Demonstrated success supporting FDA and Notified Body audits

Work Rights

US Citizens, US Permanent Residents, or protected individuals required; others subject to export licensing review

Tailored Resume

Cover Letter