Sr Quality Engineer - Pilot
Core
Support the transfer of the first sensor manufacturing line to Irvine and manage quality engineering activities for new product introductions, stabilization, and commercial manufacturing for Implantable Heart Failure Management devices.
Role type
Senior Quality Engineer (Manufacturing)
Builds
Sensor manufacturing lines and Implantable Heart Failure Management devices
Domain
Medical device manufacturing / Structural heart failure
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Engineering principles, Six Sigma, Lean methods, Risk management (FMEA, QC Plans), Change control, Test method validation, Technical documentation, Equipment validation, Training development
Preferred skills
CAD, Statistical techniques, Lab/industrial equipment operation, Leadership, Quality systems knowledge
Technologies
MS Office Suite, CAD
Responsibilities
Investigate complex manufacturing product quality and compliance issues; Optimize manufacturing and R&D processes using engineering methods; Develop and maintain risk management files; Validate test methods and associated equipment; Train technicians and lower-level employees on routine procedures
Seniority
Senior, hands-on IC