Senior Extrusion Engineer

Position Summary

The Senior Extrusion Engineer is responsible for providing the Plymouth, MN site with technical support and operating knowledge for our medical extrusion operation. This person will take the lead role in extrusion engineering functions which includes validating and troubleshooting processes, identifying and implementing process improvements, managing projects, and expanding extrusion capabilities. The engineer will work with cross-functional value-stream teams to solve issues and evaluate potential new business. The engineer will also be required to work with internal and external machine shops to design and specify tooling/fixturing. This is a hands-on role which requires on-site support and mentoring and/or managing other employees.    

Principal Responsibilities

•    Troubleshoot, implement, improve, and validate extrusion processes (melt extrusion)
•    Responsible for prioritizing projects/tasks and for strategic planning of the extrusion area(s)
•    Troubleshoot technical problems related to the production of plastic parts    
•    Contribute to cross-functional teams that enhance improvement initiatives, capital planning, project implementation, process improvement, and product development
•    Initiate, direct, and support projects to implement innovative equipment processes, and methods that enhance efficiency, improve safety, and increase profitability
•    Generate and conduct validations independently and assist technicians and engineers in executing validation protocols (IQ/OQ/PQ/TMV)
•    Design tooling to support new products or process improvements
•    Support a team of Technicians as the extrusion SME. 
•    Attend daily Value Stream meetings and present updates on engineering activities.
•    Lead continuous improvement projects focused on scrap reduction and increasing efficiency. 
•    Other duties as assigned.
 

Education / Experience Requirements

•    Bachelor’s degree in Engineering required; BS in Plastics Engineering preferred; Masters in Plastics Engineering a plus
•    5+ years of experience in an extrusion manufacturing environment, preferably in a medical device setting
•    Experience with complex multi-lumen extrusion tooling and process development highly preferred
 

Specialized Skills / Other Requirements

•    Experience in process validations, statistics and SPC using Minitab software
•    Extensive knowledge of plastic chemistry and properties 
•    Knowledge in plastic processing, tooling, and materials 
•    Experience in transferring product from development to production 
•    Experience with lean six-sigma manufacturing, preferably green or black-belt certified
•    Proficient in designing, acquiring, and implementing new equipment and processes
•    Good working knowledge of manufacturing methods, including RF plastic forming, injection molding, medical wire braiding, centerless grinding and assembly methods
•    Experienced in process controls
•    Excellent oral and written communication skills
•    Familiar with design controls, FDA regulation, and GMP practices
•    Relies heavily on experience and judgment to plan and accomplish goals
•    Working knowledge of GD&T with proficiency in SolidWorks or comparable CAD software.
•    Excellent oral and written communication skills are required. Must be able to create legible, accurate, and detailed documents that clearly communicate product and manufacturing expectations.
•    Experience with Microsoft Word, Excel and PowerPoint is required. Experience with Microsoft Project, Visio, and Minitab is preferred. 
•    Behaviors consistent to support a safety and quality driven culture.
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