Multi‑Axis CNC Machining Specialist, ISO 13485

TOMZ Manufacturing Corp•Big Lake, MN

1d•$24 - $31•Onsite

About The Position

TOMZ Corporation builds precision components for leading medical device companies. We’re certified to ISO 13485 and registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer. Expect competitive pay, 401k, health/dental, vision, PTO, and a state‑of‑the‑art, clean, and safe facility focused on continuous improvement. What You’ll Do Set up and operate Citizen and Tsugami Swiss lathes, Index multi‑spindle lathes, and 3‑/4‑/5‑axis equipment (RoboDrills, mill‑turn, horizontal/vertical mills). Perform offsets, tool changes, and in‑process adjustments with minimal supervision. Launch both legacy and new production orders, ensuring steady machine operation. Inspect parts using microscopes, micrometers, calipers, pin/thread gauges, comparators, Micro‑Hite, CMM, and vision systems. Complete inspection documentation and maintain ISO 13485 records. Execute preventive maintenance and lead problem‑solving for complex equipment/process issues. Maintain material control, identification, and traceability for conforming and nonconforming materials. Support Quality Best Practices and drive continuous improvement in GDP/GMP. Use ERP and QMS systems for documentation and traceability control. Follow safety practices, PPE guidance, and the TOMZ Quality Management System; other duties as assigned. What You Bring Experience in Class I, II, and/or III medical device manufacturing using calibrated equipment and hazardous materials. Regulated manufacturing background; aerospace, defense, or automotive experience translates well. Solid knowledge of GMP/ISO standards; ability to collaborate with R&D, Manufacturing, and QA. Proficiency with mechanical equipment operation, care, and inspection; comfortable with hand tools for PM, repairs, and tool changes. Blueprint/specification literacy and demonstrated GD&T understanding. Detail orientation, strong organization, and a knack for identifying nonconformances.

Requirements

Experience in Class I, II, and/or III medical device manufacturing using calibrated equipment and hazardous materials
Regulated manufacturing background; aerospace, defense, or automotive experience translates well
Solid knowledge of GMP/ISO standards; ability to collaborate with R&D, Manufacturing, and QA
Proficiency with mechanical equipment operation, care, and inspection; comfortable with hand tools for PM, repairs, and tool changes
Blueprint/specification literacy and demonstrated GD&T understanding
Detail orientation, strong organization, and a knack for identifying nonconformances
High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering preferred)
2–5 years in a regulated manufacturing environment
Strong verbal and written English communication skills
Bend, stoop, squat, kneel
Lift up to 50 lbs (team lift/mechanical assist over 50 lbs)
Repetitive hand/arm motions while lifting up to 20 lbs
Grip, twist, and place components for extended periods
Lift overhead
20/20 vision (assisted or unassisted) for sorting raw and non‑conforming materials
Good dexterity for small/medium products
Ability to sit or stand for long durations

Nice To Haves

Technical school certification preferred

Responsibilities

Set up and operate Citizen and Tsugami Swiss lathes, Index multi‑spindle lathes, and 3‑/4‑/5‑axis equipment (RoboDrills, mill‑turn, horizontal/vertical mills)
Perform offsets, tool changes, and in‑process adjustments with minimal supervision
Launch both legacy and new production orders, ensuring steady machine operation
Inspect parts using microscopes, micrometers, calipers, pin/thread gauges, comparators, Micro‑Hite, CMM, and vision systems
Complete inspection documentation and maintain ISO 13485 records
Execute preventive maintenance and lead problem‑solving for complex equipment/process issues
Maintain material control, identification, and traceability for conforming and nonconforming materials
Support Quality Best Practices and drive continuous improvement in GDP/GMP
Use ERP and QMS systems for documentation and traceability control
Follow safety practices, PPE guidance, and the TOMZ Quality Management System
Other duties as assigned