CNC Machinist, I – 1st and 2nd Shift

Tomz Inc; Big Lake (MN); On-site; USD 40,000 - 55,000; Full time

Benefits offered by this job

401k

Health insurance

Paid time off

Job summary

A leading manufacturer of medical devices is seeking a motivated CNC Machinist to ensure the production of high-precision components. The role includes operating advanced machining equipment and conducting inspections to maintain quality standards. Candidates should have a basic understanding of mechanical equipment and some experience in regulated manufacturing environments. This position offers competitive compensation and excellent benefits including 401k and health coverage.

Qualifications

• Minimum of 0-2 years’ experience in a regulated manufacturing environment.
• Strong verbal and written English language communication skills.

Responsibilities

• Operate and maintain 3-4-5 axis production equipment.
• Perform visual and dimensional inspections on manufactured components.
• Support problem-solving activities for complex machine or process issues.

Skills

Understanding of mechanical equipment

Attention to detail

Ability to read blueprints and specifications

Education

Basic understanding of GD&T

Knowledge of GMP/ISO standards

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 manufacturing of components through various basic functions within the 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, operate equipment, and perform visual and dimensional inspections on machine components.

Essential Functions

• Operate and maintain 3-4-5 axis production equipment, including Robo Drills, Mill Turn, and horizontal/vertical mills. Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes.
• Perform visual and dimensional inspections on manufactured components, as required using a microscope, micrometer, caliper, pin gauges, thread gauges, comparator, Micro-Hite, etc.
• Support 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 efforts of GDP/GMP.
• Utilize ERP and QMS systems to document and control inspection and traceability activities.
• Must maintain safe working conditions and follow occupational safety and health requirements including Personal Protective Equipment (PPE) guidance and rules.
• Adhere to the TOMZ Quality Management System.
• Perform other duties as assigned.

Qualifications:

Experience

• Minimum of 0-2 years’ experience in a regulated manufacturing environment.

Qualifications

• Basic understanding of the usage and care of mechanical equipment and inspection processes.
• Ability to use hand-held tools for preventive maintenance, repairs, and tool changes.
• Ability to effectively read and understand blueprints, specifications, and procedures.
• Detail-oriented with the ability to maintain accuracy and complete tasks promptly.
• Basic understanding of GD&T.
• Knowledge of GMP/ISO standards.

Preferred Skills

• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g., aerospace, defense, pharmaceutical, etc.).
• Strong verbal and written English language communication skills

Physical Demands

• 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 engineering controls may be required.
• Ability to sit or stand for prolonged periods.