CNC Machinist, IV

About the role

TOMZ Corporation is seeking a CNC Machinist to join their operations team. This position reports to the Operations Manager and involves setting up and manufacturing components within the machining department. TOMZ is a manufacturer of components for major medical device companies, operating under FDA regulations and ISO 13485 certification.

Responsibilities

• Operate and maintain CNC machines including Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes, 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.
• Maintain 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.
• Qualify and run NPI to customer specifications.
• Perform first article inspection with minimal support.
• Mentor and train 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

• 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.
• Detail-oriented with the ability to maintain accuracy and complete tasks promptly.
• Proficient reading and understanding of blueprints, specifications, and procedures.
• Advanced skills in Excel and Microsoft Word.
• Strong verbal and written English communication skills.

Education

• Certification from a Machine trades technical school program, or equivalent directly transferrable work experience in a Manufacturing or Engineering discipline preferred.
• At least ten years of relevant work experience in a regulated medical manufacturing environment, or fifteen years in a regulated medical manufacturing environment.

Physical Requirements

• 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.

Benefits

• Competitive compensation
• Excellent benefits package including 401k, health/dental, vision, and paid time off
• Modern, clean, and safe facility with state-of-the-art equipment
• Maintenance of FDA registration as a Class 2 and Class 3 Medical Device Manufacturer and ISO 13485 certification