Design Quality Engineer — Medical Devices & Regulatory

Katalyst-Healthcares-; 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

Job Description:
The Design Quality Engineer (DQE) at Philips is responsible for ensuring that products are designed and developed in compliance with regulatory standards, quality requirements, and customer expectations. This role works closely with R&D, regulatory, manufacturing, and suppliers to embed quality into product design.
Responsibilities:
Design Control:

• Ensure compliance with Design Control requirements (21 CFR Part 820 / ISO 13485) throughout product lifecycle.
• Participate in design planning, design reviews, and design verification/validation activities. (cross-functional design reviews, ensuring closure of action items).
• Review and approve design inputs, outputs, and technical documentation.
• Support traceability matrix (DHF, DMR, DHR) creation and maintenance.
• Ensure Design Verification & Validation (V&V) activities meet requirements.
• Review and approve, Engineering Change requests/Orders (ECR/ECOs).
• Ensure design changes follow proper change control processes.
• Builds and nurtures effective relationships with internal and external stakeholders, providing expert guidance and mentorship to cross-functional teams, ensuring alignment with quality standards and successful project milestones.
• Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
• Design transfer to manufacturing, ensuring process readiness.

Risk Management Support:

• Guide comprehensive risk management activities throughout the product lifecycle to ensure risks are identified and mitigated.
• Facilitate FMEA (Design and Process) and hazard analysis.
• Ensure risk controls are implemented, verified, and documented.

QMS Support (Audit, CAPA):

• Ensure preparation for quality audits and inspections, maintaining documentation to demonstrate compliance.
• Record, manage, and execute CAPA processes including root cause analysis and implementation of solutions.
• Contributes to the development, implementation, and revision of QMS processes.

Requirements:

• Bachelor's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.
• Knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation (EU MDR), Canadian Medical Devices Regulation (SOR/98-282), etc
• Change Management (Including design and Manufacturing transfer).
• Minimum of 5+ years' experience in FDA regulated medical device environments, with a focus on Design Assurance/Control, detailed knowledge of Risk.
• You have detailed experience in identifying, promoting, and supporting processes and design quality tools for use in tracking/preventing product defects, design traceability, and Design for Reliability.