Senior Design Quality Engineer

Philips

. Oversee system and hardware quality and safety risk management throughout the product life cycle .

Posted 10/2/2026full-timeUnited StatesSenior💰 $103,000 - $145,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality and safety risk management for hardware design in regulated environments, with a strong focus on compliance with industry standards such as IEC 14971 and 21 CFR 820. Proven ability to conduct technical assessments and support continuous improvement initiatives in product quality.

Highest-signal resume keywords

Quality Risk ManagementProduct Design ExperienceFMEA ExpertiseRegulated Environment ExperienceIEC Compliance Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ManagementProduct Safety Risk ManagementDesign Verification and ValidationPost-Market Product Quality AnalysisTechnical Assessment

Industry Keywords

Medical DeviceIEC 14971IEC 62304IEC 6236621 CFR 820

About the role

Key responsibilities & impact

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, product realization, and field performance
Serve as the single point of contact responsible for ensuring hardware design meets quality and compliance standards at every milestone
Perform independent technical assessments of product quality performance
Conduct post-market product quality analysis
Support Philips' quality transformation and continuous improvement efforts

Requirements

What you’ll need

Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent
2+ years of experience in product design in a regulated environment with Medical Device experience
Experience in quality, engineering, service, or manufacturing
Experience with FMEAs and Product Safety Risk Management preferred
Expertise in IEC 14971, IEC 62304, IEC 62366, and 21 CFR 820 is a plus
Must successfully perform minimum physical, cognitive, and environmental job requirements with or without accommodation
US work authorization required
Must not require sponsorship for a work-authorized visa now or in the future
Must reside in or within commuting distance to Bothell, WA; Cambridge, MA; or Reedsville, PA
5+ years of experience preferred

Benefits

Comp & perks

Annual incentive bonus may be offered
Sales commission may be offered
Long-term incentives may be offered
Generous PTO
401k with up to 7% match
HSA with company contribution
Stock purchase plan
Education reimbursement
Comprehensive Philips Total Rewards benefits program