Process Development Engineer
3 days ago
Teleflex is seeking a highly skilled Process Development Engineer to join our team. As a Process Development Engineer, you will be responsible for developing and implementing processes for medical device manufacturing.
Key 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
- 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
- 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
- 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
- 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
Teleflex is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.
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