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TOMZ Corporation · 4 months ago

CNC Machinist, IV - 1st, 2nd and Weekend Shift

Berlin, CT, US

Full-time

Onsite

Senior Level, Lead/Staff

10+ 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 the machining Department, maintaining ISO standards, and performing inspections on machine 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

Set up complex 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, vision systems

Perform scheduled and regular preventive maintenance on equipment

Lead and train in 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

Lead and train in Quality Best Practices and contribute to continuous improvement in GDP/GMP

Utilize ERP and QMS systems to document and control inspection and traceability activities

Perform Zeiss (or similar) CMM Gauge R&R activities for NPI

Perform all AQL in production with all data being entered into the ERP system

Perform Qualification runs on NPI to the customers specifications

Perform the first article inspection with minimal support

Capable of mentoring and training lower-level machinists

Perform FANUC (or similar) robot adjustments on basic programs

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 MachiningISO 13485GMP StandardsCMM InspectionBlueprint ReadingPreventive MaintenanceMicrosoft ExcelMicrosoft WordTeam CollaborationDetail-orientedVerbal CommunicationWritten Communication

Required

Experience in Class I, II, and/or III medical device manufacturing within a regulated environment using calibrated equipment and hazardous materials

Knowledge of and experience with GMP/ISO standards

Advanced understanding of mechanical equipment usage, care, and inspection processes

Ability to use hand-held tools for preventive maintenance, repairs, and tool changes

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 minimal guidance

Proficient reading and understanding of blueprints, specifications, and procedures

Detail-oriented with the ability to maintain accuracy and complete tasks promptly

Proficient in identifying nonconformances and maintaining organization

Advanced skills in Excel and Microsoft word

Strong verbal and written English communication skills

Certification from a Machine trades technical school program, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred)

Certification from a Machine trades technical school program and ten years relevant work experience in a regulated medical manufacturing environment, or fifteen years in a regulated medical manufacturing environment

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