Manufacturing Engineer II, Transfer Engineering
Core
Transition new medical devices into manufacturing through line setup, equipment qualification, process validation, and production stabilization.
Role type
Manufacturing Engineer II (Transfer Engineering)
Builds
Transcatheter Heart Valve (THV) devices for patients with cardiovascular disease
Domain
Medical device manufacturing (cardiovascular)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Six Sigma, LEAN, process validation, equipment qualification, project planning, risk analysis, technical design, CAPA resolution, training development
Preferred skills
CAD, MS Project, statistical techniques, lab/industrial equipment operation, FDA regulations knowledge, clean room protocols
Technologies
MS Office Suite, MS Project, CAD
Responsibilities
Optimize manufacturing processes using engineering methods; Develop and execute experiments to qualify and validate processes; Analyze and resolve manufacturing and compliance issues; Develop training and documentation for production; Establish project plans for deliverables; Oversee manufacturing support and instruct technicians
Seniority
Mid-level, hands-on IC
