At TOMZ, we craft precision components for life-changing Medical Devices using advanced metal machining, finishing, assembly, and anodizing. Step into our Swiss machining department and take ownership of complex setups, tight-tolerance production, and inspection excellence in a regulated environment.
A Day in This Role
You arrive to the Swiss cell, review your work orders, and begin prepping a Citizen or Tsugami lathe. You load tools, dial in offsets, and bring a legacy job back to life with steady, repeatable performance. Between cycles, you verify critical features with microscopes, micrometers, calipers, pin and thread gauges, comparators, Micro-Hite, CMM, and vision systems. When the schedule shifts, you pivot to an Index multi-spindle lathe or move to 3-, 4-, or 5-axis production equipment—including Robo Drills, mill-turn platforms, and horizontal/vertical mills—to keep delivery promises on track.
Throughout the day, you document to ISO 13485 standards, maintain material identification and traceability for both conforming and nonconforming parts, and record results in our ERP and QMS systems. You troubleshoot a stubborn surface finish, swap a tool, adjust wear offsets, and lead a quick root-cause session. You perform preventive maintenance, mentor junior machinists, and keep safety and PPE front-and-center. You collaborate with Manufacturing, R&D, and QA to refine processes—always with GDP/GMP best practices in mind.
Essential Functions
- Set up and operate Citizen and Tsugami Swiss lathes, Index multi-spindle lathes, and 3–4–5 axis production equipment (Robo Drills, mill-turn, horizontal/vertical mills).
- Perform tool changes and offsets to drive efficient, stable production with minimal support.
- Run complex legacy components and launch new production orders.
- Conduct visual and dimensional inspections using microscopes, micrometers, calipers, pin/thread gauges, comparators, Micro-Hite, CMM, and vision systems.
- Complete ISO 13485-compliant documentation and quality records; utilize ERP/QMS for traceability and inspection control.
- Ensure material control, identification, and traceability for conforming and nonconforming product.
- Lead problem-solving for challenging machine/process issues and perform scheduled preventive maintenance.
- Support Quality Best Practices and continuous improvement in GDP/GMP; contribute to a culture of improvement, quality, and on-time delivery.
- Mentor and train lower-level machinists; adhere to the TOMZ Quality Management System and all safety/PPE requirements.
Qualifications:
Education/Experience
- Certification from a technical school program or equivalent directly transferable experience in manufacturing/engineering accepted.
- Technical school certification strongly preferred.
- 3–7 years in regulated manufacturing; experience with Class I/II/III medical devices using calibrated equipment and hazardous materials.
Preferred Skills/Qualifications
- Background in aerospace, defense, or automotive manufacturing is valuable.
- Working knowledge of GMP/ISO and ISO 13485 requirements; strong understanding of machine operation, care, and inspection processes.
- Proficient in blueprint/specification interpretation and procedures; intermediate GD&T.
- Hands-on ability with hand tools for PM, repairs, and tool changes.
- Organized, detail-focused, and skilled at identifying nonconformances.
- Self-starter who can work independently and on cross-functional teams with R&D, Manufacturing, and QA.
- Strong verbal and written English communication skills.
Physical Demands
- Ability to sit or stand for prolonged periods.
- PPE such as dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.