Teleflex
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology.
Teleflex is the home of Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck – trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.
OEM –
Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. 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. 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 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 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. Familiar with FDA documentation requirements, QSR requirements for medical devices, Lean Manufacturing and Good Manufacturing Practices. Experience with Microsoft Word/Excel is required. Excellent oral and written communication skills are required. Ability to prioritize and work independently. Behaviors consistent to support a quality and safety driven culture. 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. Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, 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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Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. 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. 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 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 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. Familiar with FDA documentation requirements, QSR requirements for medical devices, Lean Manufacturing and Good Manufacturing Practices. Experience with Microsoft Word/Excel is required. Excellent oral and written communication skills are required. Ability to prioritize and work independently. Behaviors consistent to support a quality and safety driven culture. 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. Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, 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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