Medical Device Metrology Engineer

A day in the life

You start your morning refining a DMIS program on a CMM to verify a tight-tolerance implant component. By mid-day, you’ve configured a vision inspection platform and optical comparator to tackle a tricky edge profile, and you’ve built a custom workholding fixture to stabilize a delicate part for laser measurement. In the afternoon, you lead a Test Method Validation, translate insights into clear inspection instructions, and coach the team through a First Article Inspection. You wrap up by trending defect modes across product families, updating visual standards for TOMZ’s manufacturing processes, and ensuring every step aligns with the TOMZ Quality Management System (QMS).

What you’ll do

• Program and operate advanced measurement systems: vision platforms, CMMs, PLC-driven stations, optical sensors/optical comparators, and laser measurement systems.
• Serve as the GD&T subject matter expert; translate complex geometric requirements into practical, repeatable measurement strategies and robust bench layouts.
• Define and refine test methods; execute and evaluate Test Method Validations (TMVs) to ensure accuracy, precision, and repeatability.
• Design, model, and build inspection workholding/fixturing to enable stable, repeatable measurements.
• Lead Incoming, In-Process, and Final inspection execution; champion First Article Inspections (FAIs).
• Create clear, visual inspection instructions and standardized acceptance criteria; support production visual standards across TOMZ’s processes.
• Manage gage calibration activities (review, execution, evaluation) and establish calibration standards.
• Apply precision tools effectively: height gages, calipers, micrometers, depth gages, indicators, and thread/plug Go/No-Go gages.
• Leverage materials testing (chemistry and mechanical) as needed to validate product integrity.
• Drive Quality best practices and GDP/GMP continuous improvement.
• Track and report inspection data: rejection rates, defect modes, and process trends across customers and product families.
• Review ECOs for Quality Engineering document releases; adhere to the TOMZ QMS.
• Perform other duties as assigned.

What you bring

• Self-starter who thrives in a fast-paced manufacturing environment.
• Proficiency in Microsoft Office and strong written/verbal communication in English.
• Working knowledge of statistical methods and sampling strategies.

Experience required

• 4 years in a regulated manufacturing setting.
• 3 years in manufacturing quality with advanced metrology, including CMM and/or vision system programming.
• 3 years of GD&T training and measurement programming system experience.

Education

• High school diploma or GED.

Preferred credentials

• ASQ certifications (CQT, CQE, or CRE).
• DMIS programming certifications.
• Medical device (Class I/II/III) manufacturing experience.
• Background in regulated industries such as Aerospace, Defense, or Pharmaceutical.
• Familiarity with external standards: ISO 900/9001, ISO 13485, 21 CFR 820, EU MDR; experience with product development, design controls, GMP, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), CAPA, and customer complaints.

Travel

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

Physical demands

• Occasional bending, stooping, squatting, and kneeling; lift up to 30 lbs independently (team lift or mechanical aid required above 30 lbs).
• Work around oils, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, and coolants; exposure to sharp-edged materials. PPE (e.g., safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves) and engineering controls may be required.
• Extended periods of sitting; frequent keyboard and mouse use requiring manual dexterity and coordination.
• Prolonged visual focus on screens and fine features; corrective lenses may be used as needed.
• Repetitive hand and arm motions.