Lead Metrology & CMM Applications Engineer

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.

• 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.

• 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.

• 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.

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

• 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.