Dimensional Metrology Programmer – Medical Devices

Own the measurement strategy that ensures product confidence

At TOMZ, you will architect reliable inspection and test methods that keep life-changing devices within spec.

• Impact areas
• Develop metrology methods for a regulated medical device environment.
• Assess process risk; implement control mechanisms and CAPA; create and refine test methods.
• Operate/program: vision systems, CMMs, PLCs, optical comparators/sensors, and laser measurement systems.
• Be the in-house GD&T authority; resolve complex measurement challenges via expert bench/surface plate layouts.
• Define test methods with cross-functional partners; execute and evaluate Test Method Validations.
• Apply precision tools: electronic height gages, calipers, micrometers, depth gages, indicators, and plug/thread Go/No-Go gages.
• Design, model, and fabricate inspection workholding fixtures.
• Lead Incoming, In-Process, and Final inspection execution; champion First Article Inspections.
• Oversee gage calibration review/management/execution/evaluation; set calibration standards.
• Support materials chemistry and mechanical testing as needed.
• Advance Quality Best Practices and GDP/GMP continuous improvement.
• Track/report inspection metrics: rejection rates, defect modes, and process trends by customer/product family.
• Review ECOs for Quality Engineering documentation; author inspection instructions.
• Comply with the TOMZ Quality Management System; perform other duties as assigned.

Qualifications

• Self-directed in a fast-paced setting; strong English communication skills.
• Microsoft Office competence; basic statistics and sampling knowledge.

Experience

• 4+ years in regulated manufacturing.
• 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 credentials
• ASQ-CQT, CQE, or CRE; DMIS programming certifications.
• Medical device Class I/II/III experience; prior work in aerospace, defense, or pharmaceutical environments.
• Knowledge of ISO 9001, ISO 13485, 21 CFR 820, and EU MDR, including design controls, GMP, supplier qualification, auditing, QC (GD&T, Nonconforming Materials, MRB), CAPA, and complaint management.
• Travel
• Up to 5% per year; may include multiple overnight trips and occasional weekends.

Physical requirements

• Bend, stoop, squat, kneel, and lift up to 30 lbs; use team lift/mechanical assist over 30 lbs.
• Work around oil, grease, noise, solvents, dust, metal particles, sparks, coolant, and sharp-edged materials; PPE and engineering controls may be required (safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves).
• Extended sitting; proficient keyboard/mouse use; sustained visual focus with correction if needed; repetitive hand/arm motions.