TOMZ Corporation ยท 1 week ago
CNC Machinist, IV- 1st, 2nd, and Weekend
Big Lake, MN, US
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expTOMZ Corporation specializes in high precision metal machining for Medical Devices, and they are seeking a CNC Machinist to manage the set-up and manufacture of components in their machining department. The successful candidate will ensure compliance with ISO 13485 standards and perform inspections while maintaining equipment and training others.
BiotechnologyHealth CareIndustrial ManufacturingManufacturingMedical Device
Responsibilities
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
Qualification
Required
Certification from a Machine trades technical school program, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred)
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
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
Intermediate skills with Microsoft Excel and Word
Strong verbal and written English language communication skills
Company
TOMZ Corporation
TOMZ Corporation manufactures precision components for major medical devices, healthcare, laboratory diagnostics.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Tom M.
Owner, President & Chief Executive Officer
Melinda Polson
CFO
Company data provided by crunchbase