Lead Operator (Maple Plain, MN)

Smith+Nephew•Maple Plain, MN

7d•$27 - $41•Onsite

About The Position

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. The Lead Operator is a hands-on production lead who safely operates and supports manufacturing/assembly processes while coordinating day-to-day workflow for operators. This role prioritizes patient safety and product quality, ensures compliance with applicable quality system requirements (e.g., GMP/cGMP, SOPs, work instructions), and helps the team meet schedule, quality, and productivity targets through strong communication, problem-solving, and continuous improvement. This position is not offering any type of visa transfer or sponsorship now or in the future

Requirements

High school diploma or equivalent.
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.
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).
Ability to work flexible hours/days, overtime, and shift rotation as business needs require. Overtime may be expected.

Nice To Haves

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.
Ability to interpret basic prints/specifications and use common measurement tools as needed.

Responsibilities

Promote a safe, clean, and compliant work environment; follow EHS requirements and escalate hazards, incidents, and near-misses.
Execute work per SOPs/routers/work instructions; perform in-process and final inspections; identify, segregate, and communicate nonconforming material.
Help set shift priorities; coordinate staffing and job assignments; remove blockers to maintain flow and meet schedule.
Perform assembly/build/packaging operations high attention to detail and documentation accuracy.
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.
Set up, operate, and monitor equipment/fixtures; respond to faults and perform basic troubleshooting; escalate issues to Engineering/Maintenance/Quality.
Provide clear status updates and shift-to-shift handoff communication on safety, quality, output, and open issues.
Serve as a resource to operators; help onboard/train/cross-train team members; identify training gaps and support qualification activities.
Identify and implement opportunities to prevent issues, improve yields, reduce waste, and improve process capability (Lean/5S, standard work, fast changeover).
Complete production records, batch/device history documentation, and manufacturing reports; support process audits and investigations as assigned.
Collaborate with Production, Quality, Engineering, Planning, and Supply Chain to troubleshoot issues and maintain production flow.
Maintain 5S and cleanroom/controlled-area requirements (where applicable), including cleaning and organization of work areas.
Perform administrative tasks and special projects as assigned; support policy/procedure compliance and maintain positive working relationships.