Lead Operator (Maple Plain, MN)

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?

• 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 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 (https://www.smith-nephew.com/).

• 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 Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program

• Training: Hands-On, Team-Customized, Mentorship

• Extra Perks: Discounts on fitness clubs, travel and more!

The anticipated base compensation range for this position is $27,40 - $41,11 USD hourly. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidate. In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, parental leave, and generous PTO, paid company holidays annually and 8 hours of Volunteer time and a variety of wellness offerings such as EAP.

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.