Senior Engineer, NPD-Quality
Core
Senior Quality Engineer ensuring integrity and safety of groundbreaking cardiac surgery technologies throughout the product lifecycle.
Role type
Senior IC quality engineer (medical device NPD)
Builds
Safe, effective, and reliable cardiac surgical therapies and medical devices
Domain
Medical device industry / Cardiac surgery
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design control documentation, risk management, usability engineering, design verification and validation, Six Sigma, LEAN, FDA regulations, engineering principles
Preferred skills
MS Project, CAD, statistical techniques, lab/industrial equipment operation
Technologies
MS Office Suite, CAD
Responsibilities
Develop and maintain design control and risk management documentation; collaborate on test method development and design transfer; investigate quality and compliance issues; optimize manufacturing and R&D processes; train technicians and guide lower-level employees
Seniority
Senior, hands-on IC