Sr. Quality Engineer, NPD - IHFM
Core
Lead Quality Engineering support and leadership for New Product Development (NPD) of Implantable Heart Failure Management (IHFM) devices, ensuring successful design, verification, validation, and launch.
Role type
Senior Quality Engineer, New Product Development
Builds
Implantable Heart Failure Management (IHFM) medical devices
Domain
Medical Device / Structural Heart / Implantable Technology
Required skills
Design control, risk management, design verification, design validation, test method development, inspection and testing mechanisms, statistical techniques, reliability engineering, regulatory compliance
Preferred skills
Medical device industry experience, Class III device NPD experience, Design Assurance expertise, international regulatory knowledge, Six Sigma Black Belt, Quality System Lead Auditor
Technologies
MS Project
Responsibilities
Apply design control and risk management principles from concept to launch; lead development of risk management files; lead test method development and validation; develop inspection and testing mechanisms for components and assemblies; collaborate with manufacturing for product transfer and launch; ensure compliance with federal, state, and local regulations.
Seniority
Senior, hands-on IC