Senior Swiss CNC Machinist – Medical Device Components

TOMZ Manufacturing CorpBig Lake, MN
11dOnsite

About The Position

At TOMZ, precision isn’t a buzzword—it’s how lives are protected. As a Senior Swiss CNC Machinist, you’ll report to the Operations Supervisor and own the end‑to-end setup and production of components in our Swiss machining department. We build medical device parts through high‑precision machining, finishing, assembly, and anodizing, operating to ISO 13485 standards. A day in your life Begin by reviewing work orders and drawings, confirming materials and traceability in our ERP and QMS. Set up complex legacy jobs and new part numbers on Citizen and Tsugami Swiss lathes, Index multi‑spindle lathes, as well as 3‑, 4‑, and 5‑axis equipment including RoboDrills, mill‑turn, and horizontal/vertical mills. Dial in offsets and perform tool changes to stabilize cycle times and maintain throughput with minimal support. Run in‑process checks and final inspections using microscopes, micrometers, calipers, pin/thread gauges, comparators, Micro‑Hite, CMM, and vision systems. Document results against ISO 13485 and GMP expectations, compiling inspection records and ensuring material ID and traceability for both conforming and nonconforming product. Lead troubleshooting on complex process or machine issues and drive corrective actions. Complete scheduled preventive maintenance and use hand tools for minor repairs and setup changes. Coach junior machinists, model quality best practices, and contribute to continuous improvement in GDP/GMP. Maintain safe conditions, follow PPE guidance, and adhere to the TOMZ Quality Management System.

Requirements

  • Background in Class I, II, and/or III medical device manufacturing or other regulated environments (aerospace, defense, automotive) using calibrated equipment and handling hazardous materials.
  • Strong knowledge of GMP/ISO standards and ISO 13485 documentation discipline.
  • Proven self‑starter who collaborates fluidly with R&D, Manufacturing, and QA and works with limited supervision.
  • Advanced understanding of mechanical equipment set up, care, and inspection methods.
  • Ability to use hand tools for PM, repairs, and tool changes.
  • Fluent reading of blueprints, specifications, and procedures; adept at identifying nonconformances and organizing work.
  • Intermediate GD&T skill level and strong attention to detail with timely execution.
  • Technical school certification strongly preferred; directly transferable manufacturing/engineering experience may substitute.
  • 3–7 years of experience in a regulated manufacturing environment.
  • Strong verbal and written English communication skills preferred.

Responsibilities

  • Review work orders and drawings, confirming materials and traceability in our ERP and QMS.
  • Set up complex legacy jobs and new part numbers on Citizen and Tsugami Swiss lathes, Index multi‑spindle lathes, as well as 3‑, 4‑, and 5‑axis equipment including RoboDrills, mill‑turn, and horizontal/vertical mills.
  • Dial in offsets and perform tool changes to stabilize cycle times and maintain throughput with minimal support.
  • Run in‑process checks and final inspections using microscopes, micrometers, calipers, pin/thread gauges, comparators, Micro‑Hite, CMM, and vision systems.
  • Document results against ISO 13485 and GMP expectations, compiling inspection records and ensuring material ID and traceability for both conforming and nonconforming product.
  • Lead troubleshooting on complex process or machine issues and drive corrective actions.
  • Complete scheduled preventive maintenance and use hand tools for minor repairs and setup changes.
  • Coach junior machinists, model quality best practices, and contribute to continuous improvement in GDP/GMP.
  • Maintain safe conditions, follow PPE guidance, and adhere to the TOMZ Quality Management System.
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