Metrology Technician

Trelleborg Group•Menomonie, WI

22h

About The Position

This role involves assisting Engineers with tasks related to measurement method development and support in compliance with quality regulations for medical device manufacturing. The technician will set up and conduct test method validation for variable and attribute test method validation activities, including sample creation and developing test method work instructions. They will also calibrate measurement instruments and equipment, perform preventative maintenance, and develop robust measurement systems. This includes programming CMM and automated vision systems, and developing test methods for hand tools and gages. The role requires reviewing, interpreting, and analyzing Geometric Dimensional and Tolerance (GD&T) requirements, interpreting specifications, drawings, and customer documentation. The technician will initiate inspection plans for new/revised products, perform measurement system analysis (MSA), and conduct statistical analysis of inspection data. Additionally, they will support the Engineering and Supplier Quality groups, as well as Engineering, Manufacturing, and Inspection personnel. The role also involves supporting other quality activities such as customer complaints, RMA systems, CAPA, and internal/external audits. For the Senior Metrology Technician role, responsibilities include training company personnel, serving as a project team leader, providing mentorship, developing ideas for operational efficiency, managing multiple projects, and driving best practices.

Requirements

2 year degree in quality, manufacturing, engineering, or related equivalent experience
Regulated manufacturing industry experience
4 year degree in quality, manufacturing, engineering, or related Technical Field (for Senior role)
3+ years experience in manufacturing industry with quality experience (for Senior role)
Ability to read, write, speak and understand the English language (with a help of a translator, if needed)
Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
Ability to demonstrate adequate job knowledge to deliver a world class performance
Ability to challenge oneself to consistently meet all goals and deadlines
Willingness to strive for excellence by producing work that is free of errors and mistakes
Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
Commitment to making improvements company wide
Demonstrated competence using Microsoft Office, Project, Access and JMP
Comprehensive understanding of applicable Work Instructions, SOP’S, and ISO standards
Working knowledge of statistical methods associated with six sigma and quality control.
Able to perform math functions
Effective project leader
Experience with lean manufacturing principles and their implementation
Good hand/eye coordination and depth perception
Good manual dexterity
Correctable normal reading distance vision

Nice To Haves

2+ years of regulated manufacturing experience (for Technician role)
Quality certification(s) (e.g. ASQ CQE, CQT, CQA, etc.)
Class I, II and/or III Medical Device manufacturing experience.
Knowledge and experience with GMP/ISO Standards.
Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820 (210/211 and ICH Q7 as applicable) (for Senior role).

Responsibilities

Assist Engineers with tasks related to measurement method development and support in compliance with quality regulations for medical device manufacturing
Setup and conduct test method validation for variable and attribute test method validation activities, including sample creation, developing test method work instructions
In coordination with site the quality team, calibrate measurement instruments and equipment at regular intervals, and perform preventative maintenance when applicable
Develop robust measurement systems per medical device requirements, program CMM and automated vision systems, develop test methods for hand tools and gages
Review, interpret, and analyze Geometric Dimensional and Tolerance (GD&T) requirements per specifications to perform test method development and validation
Interpret specifications, drawings, customer documentation and other documents as necessary to support metrology projects
Plan, coordinate, conduct 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 Engineering and Supplier Quality group in identification of equipment and/or calibration providers.
Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product
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
Train company personnel as needed in areas such as the use of equipment, inspection methods, statistical methods, processes, and quality system.
Serve as project team leader on small projects. Schedules project activities and meets deadlines
Provide mentorship to other Engineers and Technicians through experiences and education as opportunities arise
Develop ideas and strategies to improve operational efficiency, add value, aid business performance and work towards a culture of continuous improvement
Successfully manage multiple high-profile projects simultaneously
Drive best practices through the application of effective quality engineering principals and procedures across functions