Process Development Engineer 2

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, Quality, Manufacturing and Operations 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 onsite support for troubleshooting manufacturing problems on assigned development projects.
•    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, 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 years of engineering experience is required.
•    Experience in medical device industry or in a regulated manufacturing environment (ISO, FDA, etc.) is required.
•    Experience in catheter manufacturing or development is preferred.

Specialized Skills / Other Requirements

•    Working knowledge of manufacturing processes related to catheter production including braiding, coiling, extrusion, injection molding, reflow and packaging. 
•    Proven track record for project management, problem solving, sound decision making and project completion; the ability to manage development programs across multiple locations and project teams. 
•    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.    
•    Working knowledge of GD&T with proficiency in SolidWorks or equivalent 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.
•    Ability to prioritize and work independently.
•    Behaviors consistent to support a quality and safety driven culture.

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Working Conditions / Physical Demands

The pay range for this position at commencement of employment is expected to be between ($71,100-112,700)  however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.