Senior Engineer, NPD Quality
Core
Principal Quality Engineer leading quality engineering support and leadership for New Product Development (NPD) of transcatheter heart valves, ensuring compliance with regulatory requirements and overseeing design and development processes.
Role type
Principal Quality Engineer (NPD)
Builds
Transcatheter Heart Valve (THV) devices
Domain
Medical Devices / Cardiovascular
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality engineering principles, Design control documentation, Risk management, Usability engineering, Design verification and validation, Six Sigma, LEAN methods, FDA regulations knowledge, Engineering degree
Preferred skills
MS Project, CAD, Statistical techniques, Lab/industrial equipment operation, Leadership, Problem-solving
Technologies
MS Office Suite, CAD
Responsibilities
Develop and maintain design control and risk management documentation; Collaborate with R&D and manufacturing on test method development and product launch; Investigate complex product quality and compliance issues; Optimize manufacturing and R&D processes using engineering methods; Train and coach technicians on routine procedures
Seniority
Principal, hands-on IC with leadership
