Lead Metrology & CMM Applications Engineer

    Highlights

    Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials; PPE such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required. Familiarity with ISO 9001, ISO 13485, 21 CFR 820, and EU MDR, including design controls, GMP, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), CAPA, and customer complaint handling.

    Numbers & Facts

    LocationBerlin, CT

    Description

    Step into a day where precision drives patient outcomes

    You arrive at TOMZ, open the latest print, and translate complex GD&T into a confident inspection plan. Before first shift finishes their coffee, you have a CMM program verifying a critical implant feature and a vision system queued for incoming components. By lunch, you have tuned a laser measurement routine, advised production on a new test method, and coached a teammate through a tricky bench layout. It is all part of advancing metrology in a regulated medical device environment—and it is exactly where you thrive.

    What you will own

    • Develop advanced metrology approaches for medical device manufacturing, assessing process risk and implementing effective controls, corrective and preventive actions, and refined test methods.
    • Operate and program measurement platforms: vision systems, CMMs, PLCs, optical comparators and sensors, and laser measurement systems.
    • Serve as the GD&T subject matter expert; translate complex tolerances into practical inspection strategies and bench/surface plate layouts.
    • Collaborate to define and document test methods; execute and evaluate Test Method Validations.
    • Apply precision tools expertly: electronic height gages, calipers, micrometers, depth gages, indicators, and plug/thread Go/No-Go gages.
    • Design, model, and build inspection workholding and custom fixtures.
    • Provide hands-on leadership for Incoming, In-Process, and Final inspection plans; champion First Article Inspections (FAIs).
    • Support gage calibration review, management, execution, and evaluation; establish and uphold calibration standards.
    • Contribute to materials testing (chemistry and mechanical) when needed.
    • Promote Quality Best Practices and GDP/GMP continuous improvement across the organization.
    • Track and report inspection data: rejection rates, defect modes, and process trends across customers and product families.
    • Review ECOs for releasing Quality Engineering documentation; create clear inspection instructions.
    • Adhere to the TOMZ Quality Management System and perform other duties as assigned.

    What you bring

    • Self-starter who excels in a fast-paced setting; strong English verbal/written communication.
    • Microsoft Office proficiency and a basic grounding in statistics and sampling strategies.
    • 4+ years in a regulated manufacturing environment.
    • 3+ years in manufacturing quality with advanced metrology, including CMM and/or vision system programming.
    • 3+ years of GD&T and measurement programming system training.
    • Education: High School Diploma or GED.

    Preferred

    • ASQ-CQT, CQE, or CRE; DMIS programming certifications.
    • Class I, II, and/or III medical device experience; experience in regulated industries such as aerospace, defense, or pharma.
    • Familiarity with ISO 9001, ISO 13485, 21 CFR 820, and EU MDR, including design controls, GMP, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), CAPA, and customer complaint handling.

    Travel

    • Up to 5% annually; may include multiple overnights and occasional weekends.

    Physical requirements and work environment

    • Ability to bend, stoop, squat, kneel, and lift up to 30 pounds; team lift or mechanical assist required for heavier objects.
    • Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials; PPE such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
    • Ability to sit for extended periods; proficient keyboard/mouse use; sustained computer and visual work with correction as needed; repetitive hand/arm motions.

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