Senior Principal Quality Engineer – Design Quality & Systems Excellence

Johnson & Johnson Innovative Medicine

Danvers, Massachusetts, United States of America
$122,000.00 - $212,750.00 py
Design quality excellence
System engineering principles
Design controls integration
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

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.
  • Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs.

Matching 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.

Salary

$122,000.00 - $212,750.00

Skills & Requirements

Must-have

  • design quality excellence
  • system engineering principles
  • design controls integration
  • risk management integration
  • product reliability programs
  • cross-functional initiatives
  • system-level design documentation

Nice-to-have

  • technical leader and change agent
  • smart, less invasive, personalized treatments
  • dynamic setting enables positive people

Key Requirements

  • Bachelor’s or Master’s degree in Engineering
  • 12–15+ years of experience
  • medical device development and quality engineering
  • Electromechanical software products required
  • ISO 14971 – Risk Management
  • IEC 60601 – Medical Electrical Equipment
  • FMEA (System, dFMEA, sFMEA)
  • Usability & Human Factors (IEC 62366)
  • ISO 13485 – Quality Management Systems
  • Advanced Statistics & Sampling Expertise

Work Rights

Not specified

Tailored Resume

Cover Letter