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Unify Recruit · Mooresville, North Carolina
We’re seeking an experienced
Senior Metrology Engineer
to lead dimensional inspection, measurement system development, and advanced metrology initiatives within a regulated medical device manufacturing environment.
This role will serve as a technical expert in CMM programming, GD&T, measurement uncertainty, and inspection methodology, partnering with Quality, Manufacturing, and Engineering teams to ensure product quality, regulatory compliance, and continuous improvement.
Key
Develop, optimize, and validate dimensional inspection strategies for medical device components and assemblies.
Program, troubleshoot, validate, and maintain Coordinate Measuring Machine (CMM) inspection programs and equipment.
Interpret engineering drawings, GD&T requirements, and product specifications to establish effective inspection methods.
Create inspection plans, inspection sheets, control plans, and technical documentation.
Design and validate custom gauges, fixtures, and inspection tooling.
Conduct Measurement System Analysis (MSA), including Gage R&R studies and measurement capability assessments.
Establish measurement standards, calibration requirements, and preventive maintenance procedures.
Investigate dimensional nonconformances, perform root cause analysis, and recommend corrective and preventive actions.
Support First Article Inspection (FAI), process validation, PPAP, and customer qualification activities.
Collaborate with Quality and Manufacturing Engineering to improve processes, reduce risk, and resolve dimensional issues.
Provide hands-on technical support to production teams and troubleshoot inspection challenges.
Train and mentor inspectors, CMM programmers, engineers, and production personnel.
Support internal audits, customer audits, and regulatory inspections in an ISO 13485 environment.
Evaluate new metrology technologies and drive continuous improvement in inspection efficiency, quality, and cost reduction.
Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Metrology, or a related technical field preferred; equivalent relevant experience may be considered.
5+ years of experience in metrology, dimensional inspection, or quality engineering within a precision manufacturing environment.
Advanced knowledge of Geometric Dimensioning and Tolerancing (GD&T) and engineering drawing interpretation.
Experience with measurement uncertainty, measurement system validation, and MSA, including Gage R&R.
Knowledge of ISO 13485 quality management systems and medical device manufacturing requirements.
Experience developing inspection plans, custom gauges, fixtures, and measurement methods.
Familiarity with First Article Inspection (FAI), process validation, PPAP, and corrective action methodologies.
Excellent communication skills and the ability to collaborate across Engineering, Quality, and Production teams.
Experience with calibration systems, inspection documentation, and continuous improvement initiatives.
Details
| Company | Unify Recruit |
| Location | Mooresville, North Carolina |
| Type | FULL TIME |
| Niche | None |