Systems Design Quality Engineer

Philips

Cambridge, MA, US
Base: $71,000 to $112,896; bonus/equity: annual in...
Fully remote
Fda regulated medical device experience
Iso 14971 risk management expertise
Design control and verification validation
The role supports the design control process from validating inputs to ensuring compliance with regulatory standards for medical devices

Job Summary

  • The role supports the design control process from validating inputs to ensuring compliance with regulatory standards for medical devices.
  • Candidates must have at least one year of experience in FDA regulated environments focusing on design quality and risk management.
  • Philips offers a comprehensive benefits program including a generous PTO, 401k match up to 7%, and stock purchase plans.

Matching Summary

The role supports the design control process from validating inputs to ensuring compliance with regulatory standards for medical devices.

Salary

Base: $71,000 to $112,896; Bonus/Equity: Annual incentive bonus and long-term incentives may be offered; Benefits: Generous PTO, 401k match, HSA contribution, stock purchase plan

Skills & Requirements

Must-have

  • FDA regulated medical device experience
  • ISO 14971 risk management expertise
  • Design control and verification validation
  • Root cause analysis and problem solving
  • Quality system regulations knowledge

Nice-to-have

  • ASQ certification preferred
  • Post-market surveillance analytics skills
  • Cross-functional stakeholder collaboration
  • Technical presentation abilities

Key Requirements

  • Bachelor's Degree in Engineering or related field
  • Minimum 1+ years FDA medical device experience
  • Knowledge of ISO 9001, ISO 13485, 21 CFR Part 803/806/820
  • US work authorization required without sponsorship

Work Rights

Must have US work authorization

Tailored Resume

Cover Letter