Big Lake, MN
Posted 2 days ago
Summary of Position
This position will have 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 be expected to maintain the ISO 13485 standards documentation, setup and operate equipment, and perform visual and dimensional inspections on machined components.
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.
- Must maintain safe working conditions and follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
- Other duties and responsibilities are 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
- Class I, II and/or III Medical Device manufacturing experience.
- Knowledge of and experience with 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 both independently and as part of a team.
- Ability to effectively read and understand blueprints, specifications, GD&T, and procedures.
- Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
- 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.
Pay Range: $30 – $38 an hour