Lead Machine Operator

Maple Plain

Job Advert \*\*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* **What will you be doing?** 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. **What will you need to be successful?** **Minimum Qualifications** **Education**: High school diploma or equivalent. **Experience**: * 2 years of manufacturing, assembly, or production experience (regulated manufacturing such as medical device preferred). Food or other regulated. * 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). **Competences:** * Ability to work flexible hours/days, overtime, and shift rotation as business needs require. * Overtime may be expected. **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. Work Environment \& Physical Requirements - ---------------------------------------- * Work is performed onsite in a manufacturing environment; including cleanroom and required gowning/PPE. * May be required to sit or stand for extended periods; frequent walking, bending, and use of hand tools/small components. * Must be able to lift/carry up to 50 lbs (or per site requirement); push/pull carts or materials as needed. * Good manual dexterity and vision required for inspection of components/finished product.