Senior Medical Device Quality & Risk Engineer

Regulatory Jobs; Bothell (WA); On-site; USD 103,000 - 145,000; Full time

Job summary

Philips is seeking a Senior Design Quality Engineer to lead hardware and system quality and safety risk management across the product lifecycle. The role demands independent design input oversight, V&V activities, and strong regulatory alignment in a medical device context.

The candidate will drive risk management, ensure compliance at milestones, and perform post‑market quality analysis. Office/onsite role with global Philips standards.

Qualifications

• 2+ years of experience in product design as demonstrated by a role in quality, engineering, service, or manufacturing in a regulated environment with Medical Device experience.
• 5+ years of experience preferred.
• Experience with FMEAs and Product Safety Risk Management preferred.
• Expertise in application of risk management to Medical Devices (IEC 14971), Medical Device Software Life Cycle Processes (IEC 62304), and Application of Usability Engineering to Medical Devices (IEC 62366), 21CFR820 are pluses.

Responsibilities

• Accountable for oversight of system and hardware quality and safety risk management throughout the product life cycle.
• A Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met.
• Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone
• Performs independent technical assessment on product quality performance and post‑market product quality analysis

Skills

Quality engineering

Regulated environment

Medical device experience

Education

Bachelor's/Master's Degree in Engineering

Tools

IEC 14971

IEC 62304

IEC 62366

21CFR820

Job description

Philips is seeking a Senior Design Quality Engineer to lead hardware and system quality and safety risk management across the product lifecycle. The role demands independent design input oversight, V&V activities, and strong regulatory alignment in a medical device context.

The candidate will drive risk management, ensure compliance at milestones, and perform post‑market quality analysis. Office/onsite role with global Philips standards.