Senior Quality Design Engineer
Core
Ensure patient safety and product excellence by leading design assurance activities for new and commercialized medical devices.
Role type
Senior IC quality design engineer (medical device)
Builds
Medical devices for global patient care
Domain
Medical device industry + Quality Engineering
Required skills
Risk management (ISO 14971), Design controls (ISO 13485), Verification and validation, FMEA, Hazard analysis, Design History File management, Design change control, Statistical analysis
Preferred skills
Cross-functional leadership, Mentoring, Problem-solving methodologies
Technologies
ISO 14971, ISO 13485, FMEA, Fault Tree Analysis
Responsibilities
Lead systematic problem-solving for complex product quality issues; Provide senior-level quality engineering leadership on NPD teams; Drive risk management activities (hazard analysis, FMEA); Develop and approve V&V protocols; Establish and maintain Design History File documentation; Lead design change control activities; Monitor field performance and drive CAPA; Mentor junior engineers
Seniority
Senior, hands-on IC