Senior Design Quality Engineer - Medical Devices (Hybrid)

Philips International; Bothell (WA); On-site; USD 103,000 - 145,000; Full time

Benefits offered by this job

PTO

401k (up to 7% match)

HSA (company contribution)

Stock purchase plan

Education reimbursement

Job summary

Philips is seeking a Senior Design Quality Engineer to lead quality oversight across hardware designs in a regulated medical device environment. You will coordinate design input, V&V activities, and post‑market performance while serving as the project’s quality contact.

The role emphasizes risk management per IEC 14971 and compliance to 21 CFR 820, with onsite work at Philips sites in the US. You will drive quality improvements and collaborate with cross‑functional teams.

Qualifications

• Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
• 2+ years in product design with quality/engineering/service/manufacturing in a regulated environment with Medical Device experience.
• Experience with quality oversight across design input, V&V, design transfer and field performance.

Responsibilities

• Oversee system and hardware quality and safety risk management throughout the product life cycle.
• Provide independent oversight of design input, V&V, design transfer and realization.
• Act as single point of contact to ensure hardware design meets quality and compliance standards for milestones.
• Perform independent technical assessments on product quality performance and post-market analysis.

Skills

Quality engineering

Regulatory compliance

Education

Bachelor's/Master's in Mechanical or Electronics Engineering or Science

Tools

IEC 14971

IEC 62304

IEC 62366

21CFR820

FMEAs

Product Safety Risk Management

Job description

Philips is seeking a Senior Design Quality Engineer to lead quality oversight across hardware designs in a regulated medical device environment. You will coordinate design input, V&V activities, and post‑market performance while serving as the project’s quality contact.

The role emphasizes risk management per IEC 14971 and compliance to 21 CFR 820, with onsite work at Philips sites in the US. You will drive quality improvements and collaborate with cross‑functional teams.