Multi‑Axis CNC Setup Machinist (ISO 13485)

TOMZ Manufacturing Corp; Big Lake (MN); Sur place; USD 32 000 - 42 000; Plein temps

Résumé du poste

TOMZ Manufacturing Corp. is seeking an experienced CNC Machinist to set up and operate 3- to 5-axis equipment, ensuring tight tolerances for medical components. You will perform offsets, tool changes, and prepare legacy and new jobs for stable runs.

Daily responsibilities include visual and dimensional inspections with precision instruments, maintaining ISO 13485 records, and contributing to continuous improvement under GMP/ISO guidelines. The role emphasizes strict quality and safety standards.

Qualifications

• Experience in regulated medical device manufacturing (GMP/ISO).
• Able to read blueprints and interpret GD&T.
• Proficient with precision hand tools and inspection equipment.

Responsabilités

• Set up and operate multi-axis CNC equipment; perform tool changes.
• Conduct visual and dimensional inspections using gauges and CMM.
• Maintain ISO 13485 documentation and quality records.
• Lead problem-solving for complex machine or process challenges.
• Record inspection data in ERP and QMS systems.
• Follow safety rules and wear PPE; support preventive maintenance.

Connaissances

GMP & ISO practices

Blueprint reading GD&T

Mechanical equipment operation

Hand tool use

Attention to detail

Formation

High school diploma or GED

Technical school certificate

Outils

Micrometers

Calipers

CMM

Vision systems

Description du poste

Questions and answers about the roleWho is TOMZ?TOMZ Corporation partners with major medical device companies to produce precision components. We provide competitive compensation, 401(k), health/dental, vision, and paid time off. Our facility is modern, clean, and safe, with state-of-the-art equipment. We are FDA-registered as a Class II and Class III Medical Device Manufacturer and hold ISO 13485 certification.What will I do each day?Set up and operate multi-axis equipment: Citizen/Tsugami Swiss lathes, Index multi-spindle lathes, Robo Drills, mill-turn, and horizontal/vertical mills (3-4-5 axis).Perform offsets and tool changes to sustain efficient production with minimal support.Prepare both legacy components and new jobs for stable, repeatable runs.Conduct visual and dimensional inspections with microscopes, micrometers, calipers, pin/thread gauges, comparators, Micro-Hite, CMM, and vision systems.Maintain ISO 13485-compliant documentation and compile quality records.Carry out scheduled and routine preventive maintenance.Lead problem-solving for complex machine or process challenges.Manage material identification, control, and traceability for conforming and nonconforming product.Support GDP/GMP and continuous improvement initiatives.Record inspection and traceability data in ERP and QMS systems.Follow occupational safety and health requirements and wear required PPE.Adhere to the TOMZ Quality Management System and perform other duties as assigned.Who will I report to?The position reports to the Operations Supervisor within the machining department.What qualifications are required?Experience in Class I, II, and/or III medical device manufacturing in a regulated setting; accustomed to calibrated equipment and hazardous materials.Relevant regulated manufacturing experience; background in aerospace, defense, or automotive welcomed.Knowledge of GMP and ISO practices.Self-directed and collaborative; able to partner with R&D, Manufacturing, and QA to achieve results with guidance.Proficient with mechanical equipment operation, care, and inspection practices.Comfortable using hand tools for PM, repairs, and tool changes.Can read and interpret blueprints, specifications, and procedures; understands GD&T.Detail-focused; able to identify nonconformances and stay organized to meet deadlines.What education and experience do I need?High school diploma, GED, or directly transferrable experience (Manufacturing or Engineering preferred).Technical school certification preferred.2–5 years in a regulated manufacturing environment.What are the physical requirements?Bend, stoop, squat, kneel, and lift up to 50 lbs (team lift/mechanical assist required over 50 lbs).Perform repetitive hand/arm motions while lifting up to 20 lbs; grip, twist, and place components for extended periods, including overhead handling.20/20 vision (assisted or unassisted) to sort raw and nonconforming materials; strong dexterity for small to medium products.Work around oil, grease, noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp edges; PPE (safety glasses, dust masks, ear plugs, cut- or chemical-resistant gloves) and engineering controls may be required.Ability to sit or stand for prolonged periods.When would I work and how is pay structured?Weekend Shift: 20% differential, 5:00 AM – 5:00 PM Friday–Sunday2nd Shift: 15% differential, 5:00 PM – 3:30 AM1st Shift: No differentialPay range: $23.50 – $30.50What equipment will I touch?CNC Swiss Lathe (Citizen, Tsugami, Index)CNC Mill (3–4 axis VMC)CNC Mill (5+ axis VMC)Robo Drills, mill-turn, Index multi-spindle lathes, horizontal/vertical mills