CNC Machinist, IV

Summary

Summary Of Position This position has direct responsibility for the set-up and manufacture of components within a machining department. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for medical devices. The successful candidate will maintain ISO 13485 standards documentation, set up and operate equipment, and perform visual and dimensional inspections on machined components.

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Operate and maintain production equipment within the department, including Citizen lathes, Tsugami lathes, Index multi-spindle lathes, Willemin mill-turns, various 3-4-5 axis mills, and Anodize/Passivation Lines.
• Demonstrate the ability to perform offsets and change tools to maintain efficient production with minimal support.
• Set up complex legacy components and new production orders to ensure the machine is ready for steady production.
• Perform visual and dimensional inspections on manufactured components using microscope, micrometer, caliper, pin gages, thread gages, comparator, micro-hite, CMM, vision system, etc.
• Regularly perform preventive maintenance of equipment as prescribed.
• Lead and train on 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 material through the manufacturing processes.
• Lead and train on Quality Best Practices and GDP/GMP continuous improvement efforts.
• Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.
• Fit and assemble parts into complex assemblies when required.
• Perform Zeiss (or similar) CMM Gage R&R activities for NPI.
• Perform all AQL data collection when running production with data entered into the ERP system.
• Conduct Qualification runs on NPI to customer specifications.
• Perform 1st article inspection with minimal support.
• Provide guidance and training to Machinists levels I, II & III.
• Perform FANUC (or similar) robot adjustments on basic programs.
• Maintain safe working conditions and follow occupational Safety and Health requirements, including PPE guidance and rules.
• Other duties and responsibilities as assigned.

• Certification from a machine trades technical school program, or equivalent directly transferable work experience (manufacturing or engineering discipline preferred).

• Certification from a machine trades technical school program and ten years of relevant work experience in a regulated medical manufacturing environment, or fifteen years in a regulated medical manufacturing environment.

• Class I, II and/or III Medical Device manufacturing experience.
• Knowledge of GMP/ISO standards.
• Advanced understanding of the usage and care of mechanical equipment and inspection processes.
• Ability to use hand-held tools to perform preventive maintenance or repair activities and install or change tools.
• Experience editing programs through machine controls.
• Hands-on self-starter with ability to work independently and as part of a team.
• Ability to read and understand blueprints, specifications, GD&T, and procedures.
• Maintains accuracy and attention to detail; completes tasks in a timely manner.
• Ability to work with various functional areas, including R&D, Manufacturing, and QA, with minimal guidance.

• Intermediate skills with Microsoft Excel and Word.
• Strong verbal and written English language communication skills.