Senior Design Quality Engineer — Medical Devices

philips

United States

On-site

USD 103,000 - 145,000

Full time

5 days ago

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Benefits offered by this job

PTO

401k match

HSA

Stock purchase plan

Education reimbursement

Job summary

Philips is seeking a Senior Design Quality Engineer to oversee system and hardware quality and safety across the product lifecycle. You will provide independent oversight of design input, design V&V, transfer, and field performance to ensure requirements are met.

The role requires coordinating with project teams as the single point of contact for quality and compliance at milestones. Ideal candidates have a mechanical/electronics/science background, 2+ years in regulated product design (5+ years

Qualifications

Bachelor's / Master's degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
2+ years in product design in a regulated environment with Medical Device experience; 5+ years preferred.
Experience with FMEAs and Medical Device Risk Management; knowledge of IEC 14971, IEC 62304, IEC 62366, and 21CFR820 preferred.

Responsibilities

Oversight of system and hardware quality and safety risk management throughout the product life cycle.
Independent oversight of design input process, design V&V activities, design transfer and product realization, and field performance to ensure design requirements are met.
Act as single point of contact to ensure hardware design meets quality and compliance standards for every milestone.
Performs independent technical assessment on product quality performance and post-market product quality analysis.