Quality Engineer I, NPD
Core
Quality Engineer supporting design control, manufacturing process optimization, and validation for transcardiac heart valve therapies.
Role type
Quality Engineer I, NPD
Builds
Manufacturing processes, equipment, and tools for Transcatheter Mitral and Tricuspid Therapies
Domain
Medical device manufacturing / Cardiovascular
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Engineering principles, manufacturing process optimization, design control documentation, process validation (IQ/OQ), root cause analysis, statistical methods, equipment engineering, continuous improvement (LEAN)
Preferred skills
CAD, lab/industrial equipment operation, statistical techniques, MS Project
Technologies
MS Office Suite, CAD, LEAN methods
Responsibilities
Develop manufacturing documentation (SOPs, drawings, pFMEA), support process definition and controls, execute basic experiments and tests, support equipment/tooling design, analyze compliance issues (CAPA), improve processes using engineering methods
Seniority
Entry-level IC
