Senior Principal Quality Engineer – Design Quality & Systems Excellence

J&J FAMILY OF COMPANIES

Danvers, Massachusetts, United States
Base: $122,000.00 - $212,750.00; bonus/equity: not...
On-site
Design quality excellence
Electro-mechanical, software-driven medical devices
System engineering principles
The Senior Principal Quality Engineer position at Johnson & Johnson in Danvers, MA, seeks a technical leader to drive design quality excellence in the development of complex medical devices. The role emphasizes collaboration with engineering teams and mandates extensive experience in medical device quality engineering, particularly in risk management and design controls. ###

Job Summary

  • This role partners deeply with engineering and design quality engineering to ensure robust product design through strong system engineering principles, design controls, and risk management integration.
  • The ideal candidate will lead high-impact, cross-functional initiatives to improve product reliability and robustness through reliability growth programs, design-for portability (ambulation and transport), robust algorithm and sensor system validation, motor control verification and end-to end connectivity.
  • The successful candidate will work as part of a product development team to translate system architecture, interfaces and trade-offs into robust and verifiable designs, as well as providing system-level design documentation, and ensuring overall product quality across the New Product Development (NPD) and marketed lifecycle.

Matching Summary

Match Score: 85

The Senior Principal Quality Engineer position at Johnson & Johnson in Danvers, MA, seeks a technical leader to drive design quality excellence in the development of complex medical devices. The role emphasizes collaboration with engineering teams and mandates extensive experience in medical device quality engineering, particularly in risk management and design controls. ###

Salary

Base: $122,000.00 - $212,750.00; Bonus/Equity: Not specified; Benefits: Eligible for Company’s long-term incentive program, Vacation –120 hours, Sick time - 40-56 hours, Holiday pay –13 days, Work, Personal and Family Time - up to 40 hours, Parental Leave – 480 hours, Bereavement Leave – 240/40 hours, Caregiver Leave – 80 hours, Volunteer Leave – 32 hours, Military Spouse Time-Off – 80 hours

Skills & Requirements

Must-have

  • design quality excellence
  • electro-mechanical, software-driven medical devices
  • system engineering principles
  • design controls
  • risk management integration
  • product reliability and robustness
  • ISO 14971
  • IEC 60601
  • FMEA
  • Usability & Human Factors (IEC 62366)
  • ISO 13485
  • advanced statistical methods

Nice-to-have

  • technical leader and change agent
  • cross-functional alignment
  • systems-level thinking
  • data-driven decision making

Key Requirements

  • 12–15+ years of experience
  • Bachelor’s or Master’s degree in Engineering
  • Electromechanical software products experience required
  • Experience supporting New Product Development (NPD) programs
  • Experience on console products or equivalent complex electro-mechanical/embedded systems

Work Rights

Not specified

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