Multi‑Axis CNC Machining Specialist, ISO 13485

Job Description

Job Description

Make an Impact in Medical Manufacturing at TOMZ

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.

Education & Experience

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering preferred).
• Technical school certification preferred.
• 2–5 years in a regulated manufacturing environment.
• Strong verbal and written English communication skills.

Physical Requirements

• 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.
• Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp‑edged materials; PPE and engineering controls may be required.
• Ability to sit or stand for long durations.

Schedule & Compensation

• Weekend Shift: 20% differential, 5AM–5PM Fri–Sun
• 2nd Shift: 15% differential, 5PM–3:30AM
• 1st Shift: No differential
• Pay Range: $23.50 – $30.50

Equipment You’ll Run

• CNC Mill (3–4 axis VMC)
• CNC Swiss Lathe (Citizen, Tsugami, Index)
• CNC Mill (5+ axis VMC)