Principal Engineer, NPD Quality
Core
Ensuring compliance with regulatory requirements and quality engineering principles for new product development in cardiovascular medical devices.
Role type
Principal Engineer, NPD Quality
Builds
New cardiovascular medical devices and related manufacturing/test processes
Domain
Medical device manufacturing / Structural heart innovation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality engineering principles, Design control lifecycle management, Risk management and usability file development, Six Sigma and Lean methodologies, Complex experiment and test protocol execution, Design verification and validation, Regulatory submission support, Technical documentation, Cross-functional collaboration, Team leadership and coaching
Preferred skills
CAD experience, MS Office Suite proficiency, Cleanroom medical device manufacturing knowledge
Technologies
Six Sigma, Lean, CAD, MS Office Suite
Responsibilities
Apply quality engineering principles to ensure regulatory compliance; Provide leadership for design control throughout the product development lifecycle; Develop and maintain risk management and usability files; Optimize manufacturing and R&D processes using engineering methodologies; Identify and implement solutions for equipment and technology redesign to reduce process risk; Drive development and execution of complex experiments and tests; Ensure completion of usability studies, design verification, and validation; Lead investigations into product quality and compliance issues; Serve as subject matter expert during internal and external audits; Train and coach junior engineers and technicians.
Seniority
Principal, hands-on IC with strategic oversight