Swiss/Turning CNC Set‑Up Machinist — Medical Device Precision

TOMZ Manufacturing Corp•Big Lake, MN

1d•$24 - $31•Onsite

About The Position

Join TOMZ Corporation as a Precision CNC Machinist Step into a modern, clean, and safety‑focused facility where medical devices and components are crafted to exacting standards. TOMZ Corporation is an FDA‑registered Class 2 and Class 3 Medical Device Manufacturer certified to ISO 13485. We offer competitive compensation and benefits (401k, health/dental, vision, and paid time off) and a culture rooted in continuous process improvement. A Day in the Life You arrive to a humming floor of Swiss and multi‑axis machines. Your morning starts with setting up a Citizen or Tsugami lathe for a new production order, dialing in offsets, and performing a quick tool change to hit a tight tolerance. Mid‑shift, you move to an Index multi‑spindle job, verify material traceability in the ERP/QMS, and run first‑piece checks using a microscope, micrometers, and a Micro‑Hite. Before lunch, you document inspection results to ISO 13485 requirements, troubleshoot a chip‑evacuation issue, and schedule preventive maintenance. The afternoon wraps with a visual inspection at the comparator, a CMM verification on critical dimensions, and updating nonconformance records to support GDP/GMP best practices.

Requirements

Experience in Class I, II, and/or III medical device manufacturing using calibrated equipment and hazardous materials.
Background in regulated manufacturing; experience in aerospace, defense, or automotive is applicable.
Working knowledge of GMP/ISO standards and ISO 13485 documentation discipline.
Self‑starter who works independently and collaboratively with R&D, Manufacturing, and QA to achieve results with guidance.
Hands‑on understanding of equipment operation, care, inspection processes, and use of hand tools for PM, repairs, and tool changes.
Ability to read and interpret blueprints, specifications, and procedures; solid grasp of GD&T.
Detail‑oriented, organized, and adept at identifying nonconformances.
High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
2–5 years’ experience in a regulated manufacturing environment.
Strong verbal and written English communication skills.

Nice To Haves

Technical school certification preferred.

Responsibilities

Set up and run Citizen and Tsugami Swiss lathes, Index multi‑spindle lathes, and 3‑/4‑/5‑axis production equipment (including RoboDrills, mill‑turn, and horizontal/vertical mills).
Perform offsets, tool changes, and in‑process adjustments to sustain efficient production with minimal support.
Set up legacy components and launch new production orders for steady, repeatable output.
Conduct visual and dimensional inspections with microscopes, micrometers, calipers, pin/thread gauges, comparators, Micro‑Hite, CMM, and vision systems.
Complete and compile documentation aligned with inspection standards and ISO 13485 requirements.
Drive problem‑solving efforts for complex machine or process issues and perform scheduled preventive maintenance.
Ensure material control, identification, and traceability for conforming and nonconforming materials.
Support Quality Best Practices and continuous improvement in GDP/GMP.
Use ERP and QMS systems to document inspection results and maintain traceability.
Maintain safe working conditions, follow PPE guidance, and adhere to the TOMZ Quality Management System.
Contribute to additional duties as assigned.