Precision Manufacturing Machinist -- ISO 13485

Job Description

Job Description

Make parts that make a difference

At TOMZ Corporation, we produce high-precision components for the world’s leading medical device companies in a clean, modern, and safe facility. We provide competitive compensation and benefits including 401k, health, dental, vision, and paid time off. We are FDA-registered for Class 2 and Class 3 medical devices and certified to ISO 13485.

Reporting to the Operations Supervisor, you will set up, run, and sustain production for precision components in a regulated environment—owning the process from machine setup through inspection and documentation.

• Set up, operate, and maintain Citizen and Tsugami Swiss lathes for both legacy parts and new production orders.
• Perform offsets and tool changes to maintain throughput with minimal assistance.
• Execute both scheduled and routine preventive maintenance on Swiss lathes.
• Inspect components visually and dimensionally using microscopes, micrometers, calipers, pin gauges, thread gauges, comparators, Micro-Hite, CMM, and vision systems.
• Troubleshoot and resolve complex machine and process issues; lead problem-solving activities.
• Complete ISO 13485-compliant quality documentation; compile inspection records.
• Manage material control, identification, and traceability for conforming and nonconforming product.
• Support Quality Best Practices and drive continuous improvement aligned with GDP/GMP.
• Use ERP and QMS systems to record inspections and maintain full traceability.
• Follow safety procedures and PPE requirements to maintain safe working conditions.

• Experience in Class I, II, and/or III medical device manufacturing within a regulated environment using calibrated equipment and hazardous materials.
• Strong machine math or shop math skills.
• Background in regulated manufacturing; aerospace, defense, or automotive experience is relevant.
• Working knowledge of GMP and ISO standards.
• Self-starter who collaborates across R&D, Manufacturing, and QA to achieve results with guidance.
• Knowledge of equipment operation, care, and inspection practices.
• Ability to use hand-held tools for PM, repairs, and tool changes.
• Fluent in reading blueprints, specifications, and procedures.
• Proficiency with GD&T.
• High attention to detail; able to identify nonconformances and stay organized.

• High school diploma, GED, or equivalent with directly transferrable work experience (Manufacturing or Engineering discipline preferred).
• Technical school certification preferred.
• 2–5 years in a regulated manufacturing environment.

• Clear, effective verbal and written English communication.

• Bend, stoop, squat, kneel, and lift up to 50 pounds; team lift or mechanical assist required over 50 pounds.
• Repetitive hand and arm movements while lifting up to 20 pounds; gripping, twisting, placing components for extended periods; occasional overhead lifting.
• 20/20 vision (assisted or unassisted) for sorting raw and nonconforming materials; good dexterity for small to medium parts.
• Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp edges; 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)

Bring your precision mindset to a team that prizes quality and continuous improvement. Work with advanced equipment, build life-impacting products, and grow in a stable, ISO 13485 environment.