Swiss/Turning CNC Set‑Up Machinist -- Medical Device Precision
$23.5 - $30.5 per hourTOMZ Manufacturing Corp
Job Description
Job Description
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 LifeYou 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.
What You’ll Handle- 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.
- 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).
- Technical school certification preferred.
- 2–5 years’ experience in a regulated manufacturing environment.
- Strong verbal and written English communication skills.
- Bend, stoop, squat, kneel, and lift up to 50 pounds; team lift or mechanical assist required over 50 pounds.
- Perform repetitive hand/arm movements while handling up to 20 pounds, including gripping, twisting, placing components for extended periods, and lifting overhead.
- 20/20 vision (assisted or unassisted) for sorting raw and non‑conforming materials; good dexterity for small to medium products.
- Work around oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp‑edged materials; PPE such as safety glasses, dust masks, earplugs, and cut‑resistant or chemical‑resistant gloves may be required.
- Ability to sit or stand for prolonged periods.
- 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
- CNC Mill (3–4 axis VMC)
- CNC Swiss Lathe (Citizen, Tsugami, Index)
- CNC Mill (5+ axis VMC)
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