Precision Components Production Technician (ISO 13485)

TOMZ Manufacturing Corp • Big Lake, MN

14h

About The Position

Build Devices that Matter Join TOMZ and help deliver life-changing medical device components. Reporting to the Department Manager, you will move precision parts through finishing and assembly steps, uphold ISO 13485 records, and verify component quality through detailed inspections. Our work spans precision machining, finishing, assembly, and anodizing for medical applications. What You’ll Do Own processing through key operations: Tumbling Blasting Heat treat Laser welding Laser marking Passivation Anodize Inspect parts visually and dimensionally with a microscope, micrometer, caliper, pin/thread gauges, comparator, and Micro-Hite. Create and maintain ISO 13485-compliant documentation and quality records. Manage status, identification, and traceability for conforming and nonconforming materials. Advance quality best practices and continuous improvement under GDP/GMP. Enter and manage data in ERP and QMS to control inspection evidence and traceability. Follow safety protocols and PPE expectations; adhere to the TOMZ Quality Management System. Contribute to additional tasks in support of the team. What You Bring Background in Class I, II, and/or III medical device manufacturing. Experience in regulated sectors such as Aerospace, Defense, or Pharmaceutical. Knowledge of GMP and ISO frameworks. Proficiency with mechanical metal finishing equipment and processes. Competence with basic hand tools for preventive maintenance. Ability to interpret blueprints, specifications, and work instructions. Meticulous, deadline-driven, and consistent in execution. Initiative to work independently and the teamwork to collaborate effectively. Comfort working across R&D, Manufacturing, and QA with minimal supervision. Solid organizational abilities. Education & Experience High school diploma or GED; equivalent directly transferrable experience considered (Manufacturing or Engineering preferred). 2–5 years in a regulated manufacturing environment. Communication Strong English written and verbal skills. Physical Demands & Environment Lift up to 50 lbs; use team lift or mechanical assistance above 50 lbs. Frequent bending, stooping, squatting, and kneeling. Exposure to oil, grease, noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp materials; PPE such as safety glasses, dust masks, ear plugs, and cut-resistant or chemical-resistant gloves, plus engineering controls, may be required. Ability to stand or sit for long durations.

Requirements

• Background in Class I, II, and/or III medical device manufacturing.
• Experience in regulated sectors such as Aerospace, Defense, or Pharmaceutical.
• Knowledge of GMP and ISO frameworks.
• Proficiency with mechanical metal finishing equipment and processes.
• Competence with basic hand tools for preventive maintenance.
• Ability to interpret blueprints, specifications, and work instructions.
• Meticulous, deadline-driven, and consistent in execution.
• Initiative to work independently and the teamwork to collaborate effectively.
• Comfort working across R&D, Manufacturing, and QA with minimal supervision.
• Solid organizational abilities.
• High school diploma or GED; equivalent directly transferrable experience considered (Manufacturing or Engineering preferred).
• 2–5 years in a regulated manufacturing environment.
• Strong English written and verbal skills.

Responsibilities

• Own processing through key operations: Tumbling Blasting Heat treat Laser welding Laser marking Passivation Anodize
• Inspect parts visually and dimensionally with a microscope, micrometer, caliper, pin/thread gauges, comparator, and Micro-Hite.
• Create and maintain ISO 13485-compliant documentation and quality records.
• Manage status, identification, and traceability for conforming and nonconforming materials.
• Advance quality best practices and continuous improvement under GDP/GMP.
• Enter and manage data in ERP and QMS to control inspection evidence and traceability.
• Follow safety protocols and PPE expectations; adhere to the TOMZ Quality Management System.
• Contribute to additional tasks in support of the team.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 51-100 employees