CNC Machinist II

Overview

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.

• Report to the Operations Supervisor; direct responsibility for the set-up and manufacture of components within a machining Department.
• Manufacture parts via high-precision metal machining, finishing, assembly, and anodizing processes for Medical Devices.
• Maintain ISO 13485 standards documentation; set up and operate equipment; perform visual and dimensional inspections on machined components using precision measuring equipment.
• 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 with minimal support.
• Set up 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, and vision systems.
• Perform scheduled and regular preventive maintenance on equipment.
• Drive 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.
• Support Quality Best Practices and contribute to continuous improvement in GDP/GMP.
• Utilize ERP and QMS systems to document and control inspection and traceability activities.
• 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.

• Experience in Class I, II, and/or III medical device manufacturing within a regulated environment using calibrated equipment and hazardous materials.
• Relevant job experience in regulated manufacturing, with industry experience in aerospace, defense, or automotive.
• Knowledge of and experience with GMP/ISO standards.
• 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 guidance.
• Understanding of mechanical equipment usage, care, and inspection processes.
• Ability to use hand-held tools for preventive maintenance, repairs, and tool changes.
• Effectively read and understand blueprints, specifications and procedures.
• Understanding of GD&T.
• Detail-oriented with the ability to maintain accuracy and complete tasks promptly.
• Identify nonconformances and maintain organization.

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
• Certification from a technical school program preferred.

• Minimum of 2-5 years’ experience in a regulated manufacturing environment.

• Strong verbal and written English language 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.

• 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

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