Senior Design Assurance Engineer

Philips

San Diego, CA, US
Base: $123,000 to $243,400 annually; bonus/equity:...
Fully remote
Bachelor's or master's degree in engineering
3+ years medical device qa experience
Knowledge of iso14971 and fda regulations
The primary responsibility is to work within the Quality Management System to support the Design Assurance process during the development of new medical devices

Job Summary

  • The primary responsibility is to work within the Quality Management System to support the Design Assurance process during the development of new medical devices.
  • Candidates must apply company policy and regulatory requirements to analyze situations, create risk management deliverables, and ensure compliance with internal and external standards.
  • Employees are eligible for a comprehensive benefits program including generous PTO, a 401k match up to 7%, and an annual incentive bonus.

Matching Summary

The primary responsibility is to work within the Quality Management System to support the Design Assurance process during the development of new medical devices.

Salary

Base: $123,000 to $243,400 Annually; Bonus/Equity: Annual incentive bonus, sales commission, or long-term incentives may be offered; Benefits: Generous PTO, 401k (up to 7% match), HSA, stock purchase plan, education reimbursement

Skills & Requirements

Must-have

  • Bachelor's or Master's degree in Engineering
  • 3+ years medical device QA experience
  • Knowledge of ISO14971 and FDA regulations
  • Experience with Risk Management Files and FMEAs
  • Statistical expertise for test data analysis

Nice-to-have

  • EU MDR readiness initiative experience
  • Risk Management Remediation background
  • Collaborative team-oriented mindset
  • Strong analytical problem-solving skills

Key Requirements

  • US work authorization required without sponsorship
  • Must reside in or commute from San Diego, CA
  • 3+ years experience in Quality Systems and Standards
  • Working knowledge of FDA 21CFR80.820 and Part 11

Work Rights

Must have US work authorization

Tailored Resume

Cover Letter