Senior Medical Device Quality Engineer - Design & Risk

Mass Digital Health; Massachusetts; On-site; USD 103,000 - 143,000; Full time

Benefits offered by this job

Generous PTO

401k match (up to 7%)

HSA with company contribution

Stock purchase plan

Education reimbursement

Job summary

Philips is seeking a Senior Design Quality Engineer to join our health technology team. The role focuses on leading quality and safety risk management across the product life cycle, with independent design input/V&V oversight and post-market analysis.

You will serve as the project’s single point of contact to ensure hardware design meets all quality and regulatory standards in a primarily office/onsite setting.

Qualifications

• Bachelor's or Master's degree in Engineering or Science or equivalent.
• 5+ years of experience in quality, engineering, service or manufacturing in a regulated environment with Medical Device experience.
• Experience with FMEAs and Product Safety Risk Management.
• Expertise in applying Risk Management to Medical Devices (IEC 14971), Medical Device Software Life Cycle (IEC 62304), and Usability Engineering (IEC 62366, 21CFR820) is a plus.
• You must be able to meet minimum Physical, Cognitive and Environmental job requirements for this Office/Remote position.

Responsibilities

• Oversight of system and hardware quality and safety risk management throughout the product life cycle.
• Independent oversight of design input, design V&V, 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 at milestones.
• Perform independent technical assessment on product quality performance and post-market quality analysis.

Skills

Quality Engineering

Risk Management

Regulated environment

IEC 14971

Education

Bachelor's or Master's in Engineering or Science

Job description

Philips is seeking a Senior Design Quality Engineer to join our health technology team. The role focuses on leading quality and safety risk management across the product life cycle, with independent design input/V&V oversight and post-market analysis.

You will serve as the project’s single point of contact to ensure hardware design meets all quality and regulatory standards in a primarily office/onsite setting.