Teleflex

Process Development Engineer – Level 2

Teleflex

full-time

Posted on:

Location Type: Office

Location: Plymouth • Minnesota • United States

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Salary

💰 $79,400 - $119,100 per year

About the role

  • 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.
  • 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.
  • Provide onsite support for troubleshooting manufacturing problems on assigned development projects.
  • Assume responsibility for completeness and accuracy of developed processes.
  • 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.

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.
  • 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.
  • 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.
Benefits
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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
process developmentequipment qualificationControl PlansGage R&RTest Method ValidationpFMEAproject managementmanufacturing processesGD&TSolidWorks
Soft Skills
problem solvingdecision makingcommunicationcollaborationleadership