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TOMZ Corporation · 4 months ago

CNC Machinist II- $2,500 SIGN ON BONUS

Big Lake, MN, US

Full-time

Onsite

Entry, Mid Level

2+ years exp

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. The successful candidate will be responsible for the set-up and manufacture of components within a machining department, ensuring compliance with ISO 13485 standards and conducting inspections on machined components.

BiotechnologyHealth CareIndustrial ManufacturingManufacturingMedical Device

Responsibilities

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

Qualification

CNC MachiningGMP/ISO StandardsMedical Device ManufacturingMechanical Equipment InspectionBlueprint ReadingProblem SolvingTeam CollaborationDetail-OrientedCommunication Skills

Required

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

High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred)

Minimum of 2-5 years' experience in a regulated manufacturing environment