Job Description
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 Responsibilities
* 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.
Qualifications
* 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.
* Strong hands-on experience programming and operating CMM equipment.
* 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.
* Strong analytical, troubleshooting, and root cause analysis skills.
* Excellent communication skills and the ability to collaborate across Engineering, Quality, and Production teams.
* Experience with calibration systems, inspection documentation, and continuous improvement initiatives.
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 Responsibilities
* 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.
Qualifications
* 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.
* Strong hands-on experience programming and operating CMM equipment.
* 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.
* Strong analytical, troubleshooting, and root cause analysis skills.
* Excellent communication skills and the ability to collaborate across Engineering, Quality, and Production teams.
* Experience with calibration systems, inspection documentation, and continuous improvement initiatives.
Metrology Engineer in mooresville at Unknown Company
This position is listed as full time and onsite.