Staff Engineer, New Process Development
Core
Lead engineering projects for cleaning and packaging of titanium and stainless-steel implants and instruments in an ISO7 cleanroom environment.
Role type
Staff Process Engineer (Manufacturing)
Builds
Cleaning equipment, validated manufacturing processes, and work instructions for medical implants.
Domain
MedTech / Manufacturing / Cleanroom
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation, PFMEA, Control Plans, equipment installation, supplier qualification, MES/SAP integration, operator training, analytical tools (SPC, MSA, DoE)
Preferred skills
Cleanroom experience, Vision Systems, Robot programming, GMP standards, automation, NC/CAPA initiatives
Technologies
MES, SAP, Vision Systems, Robot programming
Responsibilities
Implement and install cleaning equipment in cleanroom; provide technical leadership for manufacturing operations; develop work instructions and procedures; lead PFMEA and process validation; integrate processes with MES/SAP; train and mentor operators and engineers.
Seniority
Senior, hands-on IC
