Senior Principal Quality Engineer – Design Quality & Systems Excellence

Johnson & Johnson

Danvers, Massachusetts, United States of America
Base: $122,000.00 - $212,750.00; bonus/equity: eli...
Iso 14971 risk management for medical devices
Iec 60601 medical electrical equipment safety
Fmea system dfmea sfmea leadership
This role serves as a technical leader driving design quality excellence across complex electro-mechanical and software-driven medical devices

Job Summary

  • This role serves as a technical leader driving design quality excellence across complex electro-mechanical and software-driven medical devices.
  • The successful candidate will lead high-impact initiatives to improve product reliability through accelerated life testing, reliability modeling, and statistical demonstration.
  • Johnson & Johnson offers a competitive base pay range of $122,000.00 - $212,750.00 along with comprehensive benefits including retirement plans and paid time off.

Matching Summary

This role serves as a technical leader driving design quality excellence across complex electro-mechanical and software-driven medical devices.

Salary

Base: $122,000.00 - $212,750.00; Bonus/Equity: Eligible for long-term incentive program; Benefits: Pension, 401(k), vacation, sick time, parental leave, and more

Skills & Requirements

Must-have

  • ISO 14971 Risk Management for Medical Devices
  • IEC 60601 Medical Electrical Equipment Safety
  • FMEA System dFMEA sFMEA Leadership
  • Advanced Statistics Sampling Strategies
  • Electromechanical Software Product Development
  • Design Controls Regulatory Compliance ISO 13485

Nice-to-have

  • Change agent driving cross-functional alignment
  • Hands-on technical guidance on testing scenarios
  • Experience with console products and motor control
  • Strong communication of quantitative metrics to leadership

Key Requirements

  • Bachelor's or Master's degree in Engineering
  • 12–15+ years of experience in medical device development
  • Extensive experience supporting New Product Development programs

Work Rights

Not specified

Tailored Resume

Cover Letter