Lead Operator
Core
Hands-on production lead operating and supporting manufacturing/assembly processes while coordinating day-to-day workflow for operators in a regulated medical device environment.
Role type
Lead Operator (Production)
Builds
Medical device products
Domain
Medical Device Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/cGMP compliance, SOP execution, shift coordination, equipment setup and troubleshooting, material flow management, basic computer systems (ERP/SAP), reading technical prints/specifications, manual dexterity, lifting up to 50 lbs
Preferred skills
Prior team lead/training experience, FDA QSR/ISO 13485 knowledge, Lean Manufacturing/5S/continuous improvement tools, interpreting specifications
Technologies
SAP, Microsoft Office
Responsibilities
Promote safety and compliance (EHS), execute work per SOPs and perform inspections, coordinate staffing and job assignments, perform assembly/build/packaging operations, manage work orders and material flow, set up and monitor equipment, provide shift handoff communication, train and coach operators, implement continuous improvement initiatives, complete production records and batch documentation
Seniority
Mid-level, hands-on IC