TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a motivated CNC Machinist to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision, and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and certified to ISO 13485.
Summary of Position
Reporting to the Operations Manager, this position will have direct responsibility for the set-up and manufacture of components within the machining Department. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodizing processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation, set up and operate equipment, and perform visual and dimensional inspections on machine components.
Essential Functions
- Operate and maintain Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes 3-4-5 axis production equipment, including Robo Drills, Mill Turn, and horizontal/vertical mills.
- Perform offsets and tool changes to ensure efficient production.
- Set up complex legacy components and new production orders for steady machine operation.
- Conduct visual and dimensional inspections using microscopes, micrometers, calipers, pin gauges, thread gauges, comparators, Micro-Hite, CMM, vision systems.
- Perform scheduled and regular preventive maintenance on equipment.
- Lead and train in problem solving activities for complex machine or process issues.
- Complete and compile documentation related to quality inspection standards.
- Ensure proper material control, identification, and traceability for conforming and nonconforming materials.
- Lead and train in Quality Best Practices and contribute to continuous improvement in GDP/GMP.
- Utilize ERP and QMS systems to document and control inspection and traceability activities.
- Perform Zeiss (or similar) CMM Gauge R&R activities for NPI.
- Perform all AQL in production with all data being entered into the ERP system.
- Perform Qualification runs on NPI to the customers specifications.
- Perform the first article inspection with minimal support.
- Capable of mentoring and training lower-level machinists.
- Perform FANUC (or similar) robot adjustments on basic programs.
- Maintain safe working conditions and follow occupational safety and health requirements, including PPE guidance.
- Adhere to the TOMZ Quality Management System.
- Perform other duties as assigned.
Qualifications:
Education
- Certification from a Machine trades technical school program, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
Experience
- Certification from a Machine trades technical school program and ten years relevant work experience in a regulated medical manufacturing environment, or fifteen years in a regulated medical manufacturing environment.
Qualifications
- Experience in Class I, II, and/or III medical device manufacturing within a regulated environment using calibrated equipment and hazardous materials.
- Knowledge of and experience with GMP/ISO standards.
- Advanced understanding of mechanical equipment usage, care, and inspection processes.
- Ability to use hand-held tools for preventive maintenance, repairs, and tool changes.
- A self-starter capable of working independently and as part of a team, with the ability to collaborate across various functional areas, including R&D, Manufacturing, and QA, to achieve results with minimal guidance.
- Proficient reading and understanding of blueprints, specifications, and procedures.
- Detail-oriented with the ability to maintain accuracy and complete tasks promptly.
- Proficient in identifying nonconformances and maintaining organization.
- Advanced skills in Excel and Microsoft word.
- Strong verbal and written English communication skills.
Physical Demands
- 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.