Principal Engineer, NPD-Quality
Core
Principal Quality Engineer leading design control, risk management, and process optimization for cardiac surgical device development.
Role type
Principal Engineer, NPD-Quality
Builds
Safe, effective, and reliable cardiac surgical therapies and manufacturing processes
Domain
Medical Devices / Cardiac Surgery / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design control documentation, Risk management (ISO 14971), Six Sigma, Lean manufacturing, Design for manufacturing (DFM), Design verification and validation (V&V), Usability engineering, CAPA management, Regulatory submission support, Technical writing
Preferred skills
ASQ CQE certification, CAD, Cross-functional leadership, Audit preparation
Technologies
MS Office Suite, CAD tools
Responsibilities
Lead design control documentation and risk management files; Optimize manufacturing and R&D processes using engineering methods; Drive complex experiments, tests, and validation protocols; Investigate quality/compliance issues and lead audits; Train engineers and technicians on complex procedures
Seniority
Principal, hands-on IC with strategic influence
