Precision Machining Specialist, ISO 13485 – Complex Swiss Turning

TOMZ Manufacturing Corp•Big Lake, MN

About The Position

Do you turn complex ideas into flawless parts? Imagine taking a challenging legacy medical component from print to production—tight tolerances, intricate features, zero room for error. You study the blueprint, select tooling for a Citizen or Tsugami Swiss lathe, program offsets, and orchestrate a stable process flow. If that scenario excites you, TOMZ wants you on our team. As a Precision Machining Specialist reporting to the Operations Supervisor, you’ll manufacture medical device components through high‑precision machining, finishing, assembly, and anodizing, upholding ISO 13485 rigor at every step.

Requirements

Experience in Class I/II/III medical device manufacturing or other regulated manufacturing (aerospace, defense, automotive), using calibrated equipment and managing hazardous materials.
Working knowledge of GMP/ISO; disciplined ISO 13485 documentation habits.
Ability to collaborate across R&D, Manufacturing, and QA; self‑starter who needs minimal direction.
Advanced mechanical aptitude for equipment use, care, and inspection processes.
Confidence with hand tools for PM, repairs, and tooling changes.
Expertise in reading blueprints/specifications and following procedures; organized and detail‑oriented with strong nonconformance identification.
Intermediate GD&T capability.
Technical school certification preferred; equivalent, directly relevant manufacturing/engineering experience considered.
3–7 years in a regulated manufacturing environment.

Nice To Haves

Preferred: strong English communication skills (verbal and written).

Responsibilities

Set up and operate Swiss (Citizen, Tsugami) and Index multi‑spindle lathes, plus RoboDrills, mill‑turn, and 3‑/4‑/5‑axis horizontal and vertical mills.
Perform offsets and tool changes to optimize cycle times and quality with minimal support.
Launch new jobs and stabilize complex legacy components for steady production.
Verify parts through visual/dimensional checks using microscopes, micrometers, calipers, pin/thread gauges, comparators, Micro‑Hite, CMM, and vision systems.
Document inspections to ISO 13485 and GMP expectations; maintain material identification and traceability for conforming and nonconforming product.
Troubleshoot and resolve machine/process issues; lead problem‑solving initiatives.
Conduct scheduled preventive maintenance; use hand tools for adjustments and minor repairs.
Capture data and traceability in ERP and QMS; adhere to the TOMZ Quality Management System.
Mentor junior machinists and champion quality best practices and continuous improvement in GDP/GMP.
Maintain safe conditions and follow PPE requirements.