CNC Machinist, IV

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Ability to operate and maintain production on equipment within the department. Ex. include Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes, Willemin Mill turns, various 3-4-5 axis mills, Anodize/Passivation Lines.
• Demonstrated ability to perform offsets and change tools to maintain efficient production with minimal support.
• Ability to efficiently set up complex legacy components and complex new production orders and ensure the machine is ready for steady production.
• Perform visual and dimensional inspections on manufactured components, as required using microscope, micrometer, caliper, pin gages, thread gages, comparator, micro-hite, CMM, vision system, etc.
• Regularly and as prescribed, perform preventive maintenance of equipment.
• Lead and train on problem solving activities for complex machine or process issues.
• Completes and compiles necessary documentation related to Quality Inspection standards.
• Ensure proper material control, identification and traceability is maintained 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 needed when running production with all data entered to the ERP system.
• Perform Qualification runs on NPI to the customers specifications.
• Perform 1st article inspection with minimal support.
• Provide guidance and training to Machinists level I, II & III.
• Perform FANUC (or similar) robot adjustments on basic programs.

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: Class I, II and/or III Medical Device manufacturing experience.
• Knowledge: Knowledge of and experience with GMP/ISO standards.
• Skills: Advanced understanding of the usage and care of mechanical equipment and inspection processes.
• Experience: Experience editing programs through machine controls.
• Other: “Hands-on” self-starter with ability to work both independently and as part of a team.
• Communication: Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
• Functional Areas: Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA, as required, accomplishing results with minimal guidance.

Preferred Skills

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