Lead Operator

Key Responsibilities

• Safety & compliance: Promote a safe, clean, and compliant work environment; follow EHS requirements and escalate hazards, incidents, and near-misses.
• Quality first: Execute work per SOPs/routers/work instructions; perform in-process and final inspections; identify, segregate, and communicate nonconforming material.
• Lead daily execution: Help set shift priorities; coordinate staffing and job assignments; remove blockers to maintain flow and meet schedule.
• Hands-on production: Perform assembly/build/packaging operations; high attention to detail and documentation accuracy.
• Material flow & schedule adherence: Prioritize and manage work orders on the floor to improve lead time and mix attainment; coordinate materials, tools, gauges, and line clearances/closures as required.
• Equipment set-up & troubleshooting: Set up, operate, and monitor equipment/fixtures; respond to faults and perform basic troubleshooting; escalate issues to Engineering/Maintenance/Quality.
• Shift communication: Provide clear status updates and shift-to-shift handoff communication on safety, quality, output, and open issues.
• Training & coaching: Serve as a resource to operators; help onboard/train/cross-train team members; identify training gaps and support qualification activities.
• Continuous improvement: Identify and implement opportunities to prevent issues, improve yields, reduce waste, and improve process capability (Lean/5S, standard work, fast changeover).
• Audits & documentation: Complete production records, batch/device history documentation, and manufacturing reports; support process audits and investigations as assigned.
• Cross-functional coordination: Collaborate with Production, Quality, Engineering, Planning, and Supply Chain to troubleshoot issues and maintain production flow.
• Housekeeping: Maintain 5S and cleanroom/controlled-area requirements (where applicable), including cleaning and organization of work areas.
• Other duties: Perform administrative tasks and special projects as assigned; support policy/procedure compliance and maintain positive working relationships.

Minimum Qualifications

• Education: High school diploma or equivalent.
• Experience: 2+ years of manufacturing, assembly, or production experience (regulated manufacturing such as medical device preferred).
• Demonstrated ability to coordinate work, communicate clearly, and make day-to-day safety/quality/production decisions.
• Knowledge: Ability to read and follow work instructions, strong attention to detail and documentation accuracy.
• Comfortable using basic computer systems (e.g., Microsoft Office; ERP such as SAP is a plus).

Preferred Qualifications

• Experience: Prior experience leading or training others (lead operator, team lead, trainer, etc.).
• Medical device experience; familiarity with FDA QSR/ISO 13485 and GMP/cGMP expectations.
• Experience with Lean Manufacturing, 5S, standard work, and continuous improvement tools.
• Knowledge: Ability to interpret basic prints/specifications and use common measurement tools as needed.