Lead Operator; Maple Plain, MN

Position: Lead Operator (Maple Plain, MN)
Location: Maple Plain

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.

You Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

* Inclusion and Belonging
- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website ().

* Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement

* Work/Life Balance:
Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day

* Your Wellbeing:
Medical, Dental, Vision, Health Savings Account (Employer…