Design Quality Engineer Ii, Lifecycle

Johnson & Johnson

Danvers, Massachusetts, United States of America
Base: $92,000.00 - $148,350.00; bonus/equity: not ...
Hybrid
Design control and risk management
Fda qsr and iso 13485 compliance
Design verification and validation
This role supports and leads Design Assurance engineering activities for Abiomed’s Life Cycle processes including design controls, risk assessments, and post-market monitoring

Job Summary

  • This role supports and leads Design Assurance engineering activities for Abiomed’s Life Cycle processes including design controls, risk assessments, and post-market monitoring.
  • Johnson & Johnson offers a comprehensive benefits package including vacation, sick time, parental leave, and retirement plans.
  • The position requires ensuring compliance with FDA, ISO, and other international quality and regulatory standards while driving innovation and quality improvements.

Matching Summary

This role supports and leads Design Assurance engineering activities for Abiomed’s Life Cycle processes including design controls, risk assessments, and post-market monitoring.

Salary

Base: $92,000.00 - $148,350.00; Bonus/Equity: Not specified; Benefits: Retirement plans, paid time off, parental leave

Skills & Requirements

Must-have

  • Design control and risk management
  • FDA QSR and ISO 13485 compliance
  • Design verification and validation
  • Quality system metrics analysis
  • Manufacturing process development support

Nice-to-have

  • Leadership and mentorship skills
  • Cross-functional team collaboration
  • Statistical data analysis
  • Problem solving and continuous improvement
  • Regulatory environment knowledge

Key Requirements

  • Bachelor degree in Engineering or Sciences
  • Minimum 3 years quality experience
  • Medical device industry experience preferred
  • Cardiovascular devices experience highly preferred
  • Knowledge of FDA and ISO requirements

Work Rights

Not specified

Tailored Resume

Cover Letter