Design Quality Engineer

Responsibilities

• 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
• Support traceability matrix (DHF, DMR, DHR) creation and maintenance
• Review and approve design inputs, outputs, and technical documentation
• Support review and approval of 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
• Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements
• Supports design transfer to manufacturing, ensuring process readiness
• Supports comprehensive risk management activities throughout the product lifecycle to ensure risks are identified and mitigated
• Facilitates Failure Modes and Effects Analysis (FMEA) and hazard analysis
• Ensures risk controls are implemented, verified, and documented

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.
• Minimum of 5+ years' experience in FDA regulated medical device environments, with a focus on Design Assurance/Control, detailed knowledge of Risk
• Prior Philips experience or MRI/superconductingmagnet exposure