Design Engineer (Medical Device)

Design Quality Engineer

Work location: USA (Bothell/Cambridge)

The Design Quality Engineer (DQE) 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.

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

Minimum required Education:

Bachelor's Degree in Medical Sciences, Healthcare Management, Biomedical Engg’

Minimum required Experience:

• 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