Swiss CNC Lathe Setup Specialist (Medical Devices)
Job Description
TOMZ Corporation manufactures precision components for leading medical device companies. We offer competitive pay and a strong benefits package including 401k, health, dental, vision, and paid time off. Our modern, clean, and safe facility is equipped with state-of-the-art technology and is committed to continuous process improvement. TOMZ is FDA-registered as a Class 2 and Class 3 Medical Device Manufacturer and certified to ISO 13485.
A day in this roleReporting to the Operations Supervisor, you will own the complete setup and production of high-precision parts on Swiss CNC lathes within our machining department. Your day moves from machine setup and offsets to in-process inspection, documentation to ISO 13485 standards, and proactive problem-solving to keep production flowing.
What you will do- Set up, operate, and maintain Citizen and Tsugami Swiss lathes for legacy and new production orders.
- Perform offsets and tool changes to sustain efficiency with minimal support.
- Execute scheduled and routine preventive maintenance on Swiss lathes to ensure consistent performance.
- Conduct visual and dimensional inspections using microscopes, micrometers, calipers, pin and thread gauges, comparators, Micro-Hite, CMM, and vision systems.
- Drive root-cause analysis and problem-solving on complex machine or process issues.
- Create, complete, and compile quality documentation to ISO 13485 requirements.
- Manage material control, identification, and traceability for conforming and nonconforming materials.
- Support Quality Best Practices and continuous improvement within GDP/GMP frameworks.
- Utilize ERP and QMS systems for inspection records and full traceability.
- Maintain safe work conditions and follow occupational safety and health requirements, including PPE guidance.
- Experience in Class I, II, and/or III medical device manufacturing in a regulated environment using calibrated equipment and hazardous materials.
- Strong foundation in machine math or shop math.
- Background in regulated manufacturing; experience from aerospace, defense, or automotive is valuable.
- Knowledge of and hands-on experience with GMP and ISO standards.
- Self-starter who works independently and collaboratively with R&D, Manufacturing, and QA to achieve results with guidance.
- Understanding of mechanical equipment operation, care, and inspection processes.
- Comfort using hand tools for preventive maintenance, repairs, and tool changes.
- Ability to read and interpret blueprints, specifications, and procedures.
- Working knowledge of GD&T.
- Detail orientation with accuracy and timely task completion; able to identify nonconformances and stay organized.
- High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
- Technical school certification preferred.
- 2–5 years of experience in a regulated manufacturing environment.
- Strong verbal and written English communication skills.
- Ability to bend, stoop, squat, kneel, and lift up to 50 pounds. Team lift or mechanical assistance required for objects over 50 pounds.
- Perform repetitive hand and arm movements while lifting up to 20 pounds, including gripping, twisting, and placing components for extended periods, and lifting objects overhead.
- 20/20 vision (assisted or unassisted) required for sorting raw and non-conforming materials. Good dexterity is needed for managing small to medium products.
- Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. Personal protective equipment (PPE) such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
- Ability to sit or stand for prolonged periods.
- CNC Mill (3–4 axis VMC)
- CNC Swiss Lathe (Citizen, Tsugami)
- CNC Lathe (5+ axis) (Index)
Be part of a team advancing medical technology, working with top-tier equipment in a culture that values safety, quality, and continuous improvement—backed by competitive compensation and comprehensive benefits.
