Medical Device Design Quality Engineer

Philips; Bothell (WA); On-site; USD 110,000 - 150,000; Full time

Job summary

Philips is seeking a Product Design Quality Engineer to ensure quality, safety, reliability, and regulatory compliance across the product lifecycle. You will partner with R&D, manufacturing, regulatory, and cross-functional teams to support development from concept to commercialization and post-market monitoring.

You will apply quality engineering principles, risk management, and continuous improvement to meet customer expectations and regulatory requirements while leading CAPA and design

Qualifications

• Degree in a technical discipline with exposure to quality systems and regulated product development.
• Experience in quality engineering, design quality, safety engineering, or related fields.
• Knowledge of quality engineering principles, design controls, risk management, and regulated environments.
• Strong analytical, problem-solving, and cross-functional collaboration skills.

Responsibilities

• Develop and execute process validation strategies to support product transfers to manufacturing with regulatory compliance.
• Lead and support Design Control activities: design input reviews, verification, validation, and design transfer.
• Create and maintain quality engineering docs: quality plans, risk files, DHF, validation reports.
• Partner with cross-functional teams to integrate quality, reliability, and PMS insights into development and lifecycle.
• Conduct design/product quality assessments and root cause investigations to resolve issues.
• Evaluate critical design attributes including usability, performance, reliability, manufacturability, safety, privacy, and security.
• Lead risk management across the product lifecycle, with monitoring and controls.
• Support audits, inspections, and CAPA processes; drive continuous improvement.

Skills

Quality engineering

Design Controls

CAPA

Regulatory compliance

Risk management

Data analysis

RCA

Verification & Validation

Documentation

Product quality

Education

Bachelor's or Master's degree in Mechanical Engineering, Electrical/Electronics Engineering, Biomedical Engineering, Life Sciences, or related technical discipline

Job description

Philips is seeking a Product Design Quality Engineer to ensure quality, safety, reliability, and regulatory compliance across the product lifecycle. You will partner with R&D, manufacturing, regulatory, and cross-functional teams to support development from concept to commercialization and post-market monitoring.

You will apply quality engineering principles, risk management, and continuous improvement to meet customer expectations and regulatory requirements while leading CAPA and design