Design Quality Engineer — Medical Devices & Regulatory

Creative Solutions Services, LLC; Boston (MA); On-site; USD 110,000 - 160,000; Full time

Job summary

Philips Design Quality Engineer role focuses on ensuring products meet regulatory and customer quality expectations. The role collaborates with R&D, regulatory, manufacturing, and suppliers to embed quality in design and ensure proper design control, risk management, and QMS processes.

The candidate will participate in design planning, reviews, V&V, and change control, while mentoring cross-functional teams to align with standards and project milestones.

Qualifications

• Bachelor's degree in a relevant field (medical/engineering/healthcare).
• 5+ years in FDA-regulated medical device environments with design assurance focus.
• Knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, and related standards.
• Experience with design transfer, change control, design traceability, and V&V.
• Ability to lead cross-functional teams and mentor colleagues.

Responsibilities

• Ensure compliance with Design Control throughout the product lifecycle.
• Participate in design planning, reviews, and verification/validation activities.
• Review and approve design inputs/outputs and documentation.
• Support creation and maintenance of DHF/DMR/DHR traceability.
• Guide risk management activities and facilitate FMEA and hazard analysis.
• Prepare for quality audits and maintain documentation for compliance.

Skills

Quality leadership

Cross-functional collaboration

Design for reliability

Change management

Education

Bachelor's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, or equivalent

Job description

Philips Design Quality Engineer role focuses on ensuring products meet regulatory and customer quality expectations. The role collaborates with R&D, regulatory, manufacturing, and suppliers to embed quality in design and ensure proper design control, risk management, and QMS processes.

The candidate will participate in design planning, reviews, V&V, and change control, while mentoring cross-functional teams to align with standards and project milestones.