Senior Medical Device Quality Engineer (Hybrid)

Philips International; Washington, Northern (Washington County, KY); Hybrid; USD 103,000 - 145,000; Full time

Benefits offered by this job

PTO

401k match

HSA contribution

Stock purchase plan

Education reimbursement

Job summary

Philips seeks a Senior Design Quality Engineer to oversee hardware quality and safety risk management across the product life cycle. You will supervise design inputs, V&V activities, design transfer and field performance to ensure all requirements are met.

This is an office role with in-person collaboration, requiring on-site presence at least 3 days per week. The ideal candidate has a BS or MS in Mechanical or Electronics engineering, 2+ years in regulated medical device design, and 5+ years

Qualifications

• Bachelor's or Master's in Mechanical or Electronics Engineering or equivalent.
• 2+ years in product design with quality/engineering in a regulated environment.
• 5+ years of experience preferred.

Responsibilities

• Oversee hardware quality and safety risk management across the product life cycle.
• Provide independent oversight of design inputs, V&V, design transfer, and field performance.
• Act as single point of contact to ensure hardware design meets standards at milestones.

Skills

FMEAs and risk management

Medical device quality

IEC 14971 knowledge

IEC 62304/62366 knowledge

21 CFR 820 experience

Regulated environment

Quality oversight

Education

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

Job description

Philips seeks a Senior Design Quality Engineer to oversee hardware quality and safety risk management across the product life cycle. You will supervise design inputs, V&V activities, design transfer and field performance to ensure all requirements are met.

This is an office role with in-person collaboration, requiring on-site presence at least 3 days per week. The ideal candidate has a BS or MS in Mechanical or Electronics engineering, 2+ years in regulated medical device design, and 5+ years