CNC Machinist III- 2nd Shift (5:00 PM- 5:00 AM)

TOMZ - Big Lake, MN

Full-time

Big Lake, MN

About the position

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Machinist III 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 is certified to ISO 13485. Reporting to Department Manager, this position will have direct responsibility for the setup 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.

Responsibilities

• Operate and maintain production on equipment within the department, including Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes, Willemin Mill turns, and various 3-4-5 axis mills.
• Perform offsets and change tools to maintain efficient production with minimal support.
• Setup complex legacy components and basic new production orders to ensure the machine is ready for steady production.
• Perform visual and dimensional inspections on manufactured components using various inspection tools.
• Perform preventive maintenance of equipment regularly.
• Drive problem solving activities for complex machine or process issues.
• Complete and compile necessary documentation related to Quality Inspection standards.
• Ensure proper material control, identification, and traceability for conforming and nonconforming material.
• Support Quality Best Practices and GDP/GMP continuous improvement efforts.
• Utilize and navigate ERP and QMS systems for inspection and traceability documentation.
• Maintain safe working conditions and follow occupational Safety and Health requirements.
• Adhere to the TOMZ Quality Management System.
• Perform other duties and responsibilities as assigned.

Requirements

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
• Certification from a technical school program strongly preferred.
• Minimum of 3-7 years' experience in a regulated manufacturing environment.
• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.).
• 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 for preventive maintenance or repair activities.
• Ability to read and understand blueprints, specifications, and procedures.
• Attention to detail and ability to complete tasks in a timely manner.
• Ability to work with various functional areas, including R&D, Manufacturing, and QA.

Nice-to-haves

• Strong verbal and written English language communication skills.

Benefits

• 401k
• Health insurance
• Dental insurance
• Vision insurance
• Paid time off