Precision Manufacturing Machinist — ISO 13485

TOMZ Manufacturing Corp; Berlin (CT); On-site; USD 52,000 - 76,000; Full time

Benefits offered by this job

401k

Health insurance

Dental insurance

Vision insurance

Paid time off

Job summary

TOMZ Corporation in Connecticut is a regulated medical device manufacturer seeking skilled machinists to set up, operate, and maintain Swiss lathes and CNC equipment. You will perform inspections, document results, and participate in continuous improvement within a GMP/ISO 13485 environment.

Ideal candidates have 2–5 years in regulated manufacturing, strong GD&T, blueprint reading, and teamwork. This on-site role offers competitive compensation and full benefits in a safety-focused facility.

Qualifications

• 2–5 years in a regulated medical device manufacturing environment.
• Experience with GMP and ISO standards.
• Fluent in English reading and writing; strong documentation discipline.
• Able to use hand-held tools for PM, repairs and tool changes.

Responsibilities

• Set up, operate, and maintain CNC lathes for legacy and new production.
• Perform offsets and tool changes to maintain throughput.
• Inspect components visually and dimensionally; document results.
• Complete ISO 13485 documentation and maintain traceability.
• Troubleshoot machine/process issues and drive improvements.

Skills

GD&T

Blueprint reading

Problem solving

Attention to detail

Team collaboration

Self-starting

Education

High school diploma/GED

Technical school certification

Tools

Citizen Swiss lathe

Tsugami Swiss lathe

CNC Lathe (Index)

CNC Mill (VMC)

Job description

Make parts that make a differenceAt TOMZ Corporation, we produce high-precision components for the world’s leading medical device companies in a clean, modern, and safe facility. We provide competitive compensation and benefits including 401k, health, dental, vision, and paid time off. We are FDA-registered for Class 2 and Class 3 medical devices and certified to ISO 13485.The impact you will haveReporting to the Operations Supervisor, you will set up, run, and sustain production for precision components in a regulated environment—owning the process from machine setup through inspection and documentation.Core responsibilitiesSet up, operate, and maintain Citizen and Tsugami Swiss lathes for both legacy parts and new production orders.Perform offsets and tool changes to maintain throughput with minimal assistance.Execute both scheduled and routine preventive maintenance on Swiss lathes.Inspect components visually and dimensionally using microscopes, micrometers, calipers, pin gauges, thread gauges, comparators, Micro-Hite, CMM, and vision systems.Troubleshoot and resolve complex machine and process issues; lead problem-solving activities.Complete ISO 13485-compliant quality documentation; compile inspection records.Manage material control, identification, and traceability for conforming and nonconforming product.Support Quality Best Practices and drive continuous improvement aligned with GDP/GMP.Use ERP and QMS systems to record inspections and maintain full traceability.Follow safety procedures and PPE requirements to maintain safe working conditions.What you bringExperience in Class I, II, and/or III medical device manufacturing within a regulated environment using calibrated equipment and hazardous materials.Strong machine math or shop math skills.Background in regulated manufacturing; aerospace, defense, or automotive experience is relevant.Working knowledge of GMP and ISO standards.Self-starter who collaborates across R&D, Manufacturing, and QA to achieve results with guidance.Knowledge of equipment operation, care, and inspection practices.Ability to use hand-held tools for PM, repairs, and tool changes.Fluent in reading blueprints, specifications, and procedures.Proficiency with GD&T.High attention to detail; able to identify nonconformances and stay organized.Education and experienceHigh school diploma, GED, or equivalent with directly transferrable work experience (Manufacturing or Engineering discipline preferred).Technical school certification preferred.2–5 years in a regulated manufacturing environment.Preferred skillsClear, effective verbal and written English communication.Physical demands and environmentBend, stoop, squat, kneel, and lift up to 50 pounds; team lift or mechanical assist required over 50 pounds.Repetitive hand and arm movements while lifting up to 20 pounds; gripping, twisting, placing components for extended periods; occasional overhead lifting.20/20 vision (assisted or unassisted) for sorting raw and nonconforming materials; good dexterity for small to medium parts.Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp edges; 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.Equipment you will useCNC Mill (3–4 axis VMC)CNC Swiss Lathe (Citizen, Tsugami)CNC Lathe (5+ axis) (Index)Grow with TOMZBring your precision mindset to a team that prizes quality and continuous improvement. Work with advanced equipment, build life-impacting products, and grow in a stable, ISO 13485 environment.