Staff Process Engineer
Core
Lead the transfer of new products and design changes from design to commercial manufacturing, optimizing processes for quality, efficiency, and scalability in a regulated medical device environment.
Role type
Staff Process Engineer (Manufacturing)
Builds
Commercial manufacturing processes and product transfers for continuous glucose monitoring (CGM) devices
Domain
Medical Devices / Biosensing / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design transfer, Design controls, Statistical methods (Gauge R&R, DOE), Risk mitigation, Change management, Document control, Manufacturing Execution Systems (MES), Lean manufacturing, Technical project management
Preferred skills
JMP, Minitab, FMEA, Validation plans, Process validation strategies
Responsibilities
Lead cross-functional teams to implement new products or design changes into manufacturing; Utilize statistical methods to identify key process variables and optimize manufacturing processes; Work with Ops, Manufacturing, R&D, and Quality to support NPI transfer and scale-up; Plan, manage, and prioritize tasks/projects to maintain manufacturing KPIs; Provide input to Design and Process requirements including FMEAs and Validation Plans
Seniority
Senior, hands-on IC
