Process Development Engineer II

Position Summary

This hands-on Engineering position will provide Teleflex Medical OEM with technical support and operating knowledge for our medical device operation. This role will conduct critical engineering functions such as validation, troubleshooting, and identifying and implementing process improvements. The engineer will work with cross-functional teams to support transfer of products between sites as well as into production. The role will also be required to work with internal and external vendors to design and specify tooling/fixturing.  This position will focus on developing various processes and implementing those into production through thorough validations by working closely with R&D and Quality teams.

Principal Responsibilities

•    Establish processes based on product specifications.
•    Develop processes, fixtures, and equipment for site requirements.
•    Support Production and R&D with frequent communication.
•    Ensure that proper technology processes are developed, implemented, maintained and documented to successfully transfer development products to Production. Involved in prototyping, process development, confirmation runs, and validation. 
•    Perform equipment and process qualifications (IQ/OQ/PQ).
•    Develop Control Plans, Gage R&R’s, Test Method Validations, and pFMEA.
•    Transfer product/processes from R&D to Manufacturing using project management, Design for Manufacturability and cost, process/design excellence, ergonomics, and knowledge transfer methodologies to ensure effective implementation of equipment, processes, and new technology.
•    Provide both remote and onsite support for troubleshooting manufacturing problems at Plymouth and Maple Grove sites.
•    Assume responsibility for completeness and accuracy of developed processes (i.e., lead, manage, communicate, complete documentation, train) including ownership of process capability, process quality, and process costs.
•    Maintain knowledge of new developments in manufacturing and design technologies.
•    May lead or serve as member on cross-functional project teams.
•    Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
•    Perform other related duties and responsibilities, on occasion, as assigned.
 

Education / Experience Requirements

•    Bachelor’s degree in Engineering with a focus in Plastics, Biomedical, Mechanical or related technical field is required.
•    A minimum of 2 year’s experience in a manufacturing environment required. Medical device manufacturing industry or other heavily regulated industry is preferred.
•    Experience in catheter manufacturing or development is preferred.
 

Specialized Skills / Other Requirements

•    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.
•    Proven track record for project management, problem solving, sound decision making and project competitions; the ability to manage development programs across multiple locations and project teams. 
•    Working knowledge of manufacturing processes related to catheter production, molding, and extrusion. 
•    Familiar with FDA documentation requirements, QSR requirements for medical devices, Lean Manufacturing, and Good Manufacturing Practices.  
•    Experience with Microsoft Word/Excel is required.  Experience with Solidworks, Microsoft Project, and MiniTab is preferred.    
•    Ability to prioritize and work independently.
•    Behaviors consistent to support a quality and safety driven culture.

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