We are looking for a Design Quality Engineer with strong experience in medical devices to ensure product safety, performance, and compliance throughout the product lifecycle. The role involves close collaboration with design, manufacturing, and quality teams to support design control and regulatory requirements.
Key Responsibilities
- Ensure compliance with medical device regulations and standards (FDA 21 CFR 820, ISO 13485, ISO 14971)
- Review surgical techniques, labeling, and IFUs
- Validate design inputs and outputs, including CTQ identification and GD&T application
- Support design reviews, fixture/gauge development, and DFM/DFI inputs
- Lead and participate in risk management activities (FMEA, hazard analysis)
- Oversee design verification and validation activities
- Maintain and control Design History Files (DHF) and related documentation
- Ensure adherence to design assurance and quality system processes
- Handle manufacturing CAPA and production non-conformance activities
- Perform test method validation
- Support post-market surveillance and quality issue analysis
Qualifications & Experience
- Bachelor’s degree in Mechanical Engineering
- Minimum 8+ years of experience as a Design Quality Engineer in the medical device industry
- Strong understanding of design control processes and regulatory compliance
- Hands-on experience in CAPA, non-conformance, risk management, and validation activities
