Job Description

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

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• Develop, optimize, and validate dimensional inspection strategies for medical device components and assemblies.
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• Program, troubleshoot, validate, and maintain Coordinate Measuring Machine (CMM) inspection programs and equipment.
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• Interpret engineering drawings, GD&T requirements, and product specifications to establish effective inspection methods.
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• Create inspection plans, inspection sheets, control plans, and technical documentation.
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• Design and validate custom gauges, fixtures, and inspection tooling.
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• Conduct Measurement System Analysis (MSA), including Gage R&R studies and measurement capability assessments.
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• Establish measurement standards, calibration requirements, and preventive maintenance procedures.
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• Investigate dimensional nonconformances, perform root cause analysis, and recommend corrective and preventive actions.
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• Support First Article Inspection (FAI), process validation, PPAP, and customer qualification activities.
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• Collaborate with Quality and Manufacturing Engineering to improve processes, reduce risk, and resolve dimensional issues.
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• Provide hands-on technical support to production teams and troubleshoot inspection challenges.
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• Train and mentor inspectors, CMM programmers, engineers, and production personnel.
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• Support internal audits, customer audits, and regulatory inspections in an ISO 13485 environment.
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• Evaluate new metrology technologies and drive continuous improvement in inspection efficiency, quality, and cost reduction.
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Qualifications

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• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Metrology, or a related technical field preferred; equivalent relevant experience may be considered.
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• 5+ years of experience in metrology, dimensional inspection, or quality engineering within a precision manufacturing environment.
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• Strong hands-on experience programming and operating CMM equipment.
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• Advanced knowledge of Geometric Dimensioning and Tolerancing (GD&T) and engineering drawing interpretation.
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• Experience with measurement uncertainty, measurement system validation, and MSA, including Gage R&R.
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• Knowledge of ISO 13485 quality management systems and medical device manufacturing requirements.
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• Experience developing inspection plans, custom gauges, fixtures, and measurement methods.
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• Familiarity with First Article Inspection (FAI), process validation, PPAP, and corrective action methodologies.
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• Strong analytical, troubleshooting, and root cause analysis skills.
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• Excellent communication skills and the ability to collaborate across Engineering, Quality, and Production teams.
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• Experience with calibration systems, inspection documentation, and continuous improvement initiatives.
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