Senior Design Quality Engineer
philips · Bothell
Job description
About the role
Philips is seeking a Senior Design Quality Engineer to lead system and hardware quality and safety risk management across the product life cycle. You will provide independent oversight of design inputs, verification & validation, design transfer, and field performance to ensure compliance with the highest quality standards.
Key responsibilities
- Oversee system and hardware quality and safety risk management throughout the product life cycle.
- Provide independent oversight of design input, design V&V, design transfer, and product realization activities.
- Act as the single point of contact ensuring hardware design meets quality and compliance standards at every milestone.
- Conduct independent technical assessments of product quality performance and post‑market quality analysis.
Required profile
- Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
- At least 2 years of experience in product design within a regulated environment, preferably with medical device experience (5 + years preferred).
- Experience with FMEAs and product safety risk management is preferred.
- Knowledge of IEC 14971, IEC 62304, IEC 62366 and 21 CFR 820 is a strong plus.
Required skills
- FMEA (Failure Mode and Effects Analysis)
- Risk management for medical devices (IEC 14971)
- Medical device software life‑cycle processes (IEC 62304)
- Usability engineering for medical devices (IEC 62366)
- Compliance with 21 CFR 820
What we offer
- Comprehensive Philips Total Rewards benefits program including generous PTO, 401(k) with up to 7 % match, HSA contributions, stock purchase plan and education reimbursement.
- Competitive salary range of $103,000‑$145,000 annually and potential annual incentive bonuses.
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Published 1 month ago
Expires 1 week from now
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philips
Bothell
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