CNC Machinist II

TOMZ Corporation; Minnesota; On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

401k

Health insurance

Dental insurance

Vision insurance

Paid time off

Job summary

TOMZ Corporation, a leader in medical device manufacturing, is seeking a motivated CNC Machinist to join our operations. You will set up and machine components with precision, conduct inspections, and ensure traceability per GDP/GMP standards.

Responsibilities include maintaining equipment, following ISO 13485 documentation, and collaborating across R&D, Manufacturing, and QA to achieve high-quality results in a clean, safe facility in Minnesota.

Qualifications

• Experience in Class I, II, and/or III medical device manufacturing.
• Regulated manufacturing environment with GMP/ISO experience.
• Self-starter capable of working independently and in a team.
• Ability to read blueprints and perform GD&T.
• Familiar with inspection tools and CMM/vision systems.
• High school diploma or GED; technical certs preferred.

Responsibilities

• Operate and maintain CNC machinery and related equipment.
• Set up production orders and ensure steady operation.
• Perform visual and dimensional inspections with precision instruments.
• Maintain documentation per ISO 13485 and GDP/GMP.
• Support quality best practices and continuous improvement.
• Adhere to safety policies and company procedures.

Skills

CNC Machining

Quality Inspection

GMP/ISO knowledge

Blueprint reading

GD&T

Team collaboration

Education

High school diploma or GED

Tools

Citizen Lathes

Tsugami Lathes

Index multi-spindle lathes

Robo Drills

CMM

Vision systems

Job description

Job Description

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a motivated CNC Machinist to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision, and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and certified to ISO 13485.

Summary of Position:

Reporting to the Operations Supervisor, 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 anodizing processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation, set up and operate equipment, and perform visual and dimensional inspections on machined components using various precision measuring equipment.

Essential Functions:

• Operate and maintain Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes 3-4-5 axis production equipment, including Robo Drills, Mill Turn, and horizontal/vertical mills. Perform offsets and tool changes to ensure efficient production with minimal support.

• Set up 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, and vision systems.

  • Perform scheduled and regular preventive maintenance on equipment.
  • Drive 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 materials.
  • Support Quality Best Practices and contribute to continuous improvement in GDP/GMP.
  • Utilize ERP and QMS systems to document and control inspection and traceability activities.
  • 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.
• Relevant job experience in regulated manufacturing, with industry experience in aerospace, defense, or automotive.
• Knowledge of and experience with GMP/ISO standards.
• 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 guidance.
• Understanding of mechanical equipment usage, care, and inspection processes.
• Ability to use hand-held tools for preventive maintenance, repairs, and tool changes.
• Effectively read and understand blueprints, specifications and procedures.
• Understanding of GD&T.
• Detail-oriented with the ability to maintain accuracy and complete tasks promptly.
• Identify nonconformances and maintain organization.

Education:

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
• Certification from a technical school program preferred.

Experience:

• Minimum of 2-5 years’ experience in a regulated manufacturing environment.

Preferred Skills:

• Strong verbal and written English language communication skills.

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