Metrology Engineer

Trelleborg - Plymouth, MN

Full-time - Mid Level

Plymouth, MN

Management of Companies and Enterprises

About the position

The Metrology Engineer at Trelleborg Medical Solutions is responsible for planning and coordinating metrology activities to support tooling, automation, fixture, and medical device manufacturing. This role involves advancing the organization's metrology capabilities, collaborating with New Product Development (NPD) teams, and ensuring compliance with quality standards and regulations relevant to medical device manufacturing.

Responsibilities

• Lead, develop, and support measurement methods in compliance with quality regulations for medical device manufacturing
• Program CMM and automated vision systems, develop test methods for other tools and gages
• Review, interpret, analyze Geometric Dimensional and Tolerance (GD&T) requirements per specifications to perform test method development and validation
• Provide direction to internal teams to apply GD&T principles to internal designs
• Perform or provide guidance to Metrology Technician or Inspectors on complex First Article Inspection (FAI), prototyping, tool/fixture verification measurements
• Mentor Engineers and Technicians in troubleshooting of metrology equipment and gages, including repair and maintenance of advanced metrology equipment
• Recommend equipment, sampling plans, and measurement techniques for inspection
• Work with the Supplier Quality group to ensure equipment and calibration provider is acceptable and qualified before use
• Provide recommendations on advancing metrology capabilities, identifying equipment and skills needed to support the organization's growth strategy
• In conjunction with the NPD team, plan, develop and conduct equipment, software, test method, and/or process validation within the metrology scope
• Draft protocols and reports for Equipment Qualification (IQ/EQ), Software validation (SV), Test Method Validation (TMV), Process validation (IQ/OQ/PQ) for metrology
• Review specifications, drawings, quality agreements, customer documentation and other documents as necessary to support NPD projects
• Plan, coordinate, oversee Test Method Development and Validation activities, Initiate inspection plans for new/revised product
• Perform measurement system analysis (MSA) for Gage 1, Gage Repeatability and Reproducibility (GRR), Bias and Linearity, Resolution studies
• Perform statistical analysis of inspection data, process characterization, DOE results, ANOVA, Capability Analysis
• Support the risk management process identifying, estimating, evaluating, controlling, and monitoring risk, utilizing risk tools such as Process Failure Modes and Effects Analysis (pFMEA), CAPA etc.
• Author and executes Quality Plans for Quality Management Systems and Organizational Objectives projects
• Initiate and perform root cause analysis, uses statistical and capability analysis to solve problems
• Adhere to the company's Quality System (QS), writes, and approves QS documents
• Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product
• Communicate with customers on clarification of specifications, completing customer documents, complaints, process changes, and other projects as needed
• Understand regulatory requirements (e.g. ISO13485, 9001, 14971, FDA 21 CFR 820, ITAR)
• Provide periodic work direction and assistance to QA inspectors, QA technicians and Quality Engineering Technicians
• Support internal audit program as necessary
• Support other quality activities as necessary such as customer complaint (CC) and RMA system per procedures, corrective and preventive actions (CAPA)
• Support internal and external audits

Requirements

• 4 year degree in mechanical engineering or any related field
• 2+ years in a manufacturing environment in a technical support role
• Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable)

Nice-to-haves

• ASQ Certified Quality Engineer
• Formal Six Sigma Yellow/ Green belt training

Benefits

• Competitive salary
• Generous benefits package: Health, Dental, Vision, STD, LTD, Life, 401k
• Paid time off
• Paid holidays