Senior R&D Engineer **Date:** Mar 5, 2025 **Location:** Plymouth, MN, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ID** :11904 **About Teleflex Incorporated** 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. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, 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. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives. **Position Summary** This position's responsibility is for managing and developing new products, while interfacing with customers, vendors, and internal departments to achieve the desired product specification. The goal is to develop products, define specifications to establish reasonable timelines while developing high quality products that meet the end user’s expectations. Relies heavily on meeting dates, accountability while using experience and judgment to develop products and meet goals with minimal supervision. **Principal Responsibilities** The Senior R&D Engineer is responsible for responding to Requests for Quotes, managing quick turn medical device OEM projects, and prototyping catheters and balloon sub-assemblies. Candidate must be able to work with minimal supervision in a fast-paced, customer-centric environment; should enjoy communicating with customers, vendors, and internal departments; and be passionate about our goal of consistent on-time delivery of high quality products. This position is ideally suited for experienced Engineers that like to roll up their sleeves and spend time on the production floor, enjoy autonomy, and quick results from their efforts. • Hands-on catheter/balloon design, development, and assembly • Accurately predict project costs, material lead times, and product delivery schedules during the quoting process. • Develop bills of materials and assembly method, and provide any needed training to technicians and assemblers. Will work with many areas including: complex catheters including steerable catheters, smart catheters, complex shape balloons, handle design, molding, braiding, tipping, coating, extruding. • Develop balloons and catheter subassemblies according to customer design, performance, and quality specifications; on time and within budget. • Develop products and processes that are reliable as well as identify risks to the project, develop contingency plans, while outlining deliverables and milestones • Directs and coordinates activities to develop products and ensure progress as the product specifications/limitations are developed into the technical specification • Review and prepare status reports, modify schedules, and project plans as required • Keeps stakeholders, customers, and others informed of project status and/or related issues • Provide technical leadership, root cause analysis, and resolve customer or project related problems; materials, assembly, functional, or manufacturing related • Apply design controls from initial customer requests throughout the products life cycle • Writing, monitoring, managing, and reviewing protocols, including verification and validation tests, ECN, SOP's, BOM's, drawings, and may include calculation and/or FMEA etc...as required to develop, support, or maintain technical documentation • Intimately involved in developing protocols, including verification and validation testing, drawings, calculation and/or FMEA etc...to develop and support technical documentation • Collaborate to develop quality assurance, testing, regulatory compliance, and quality plans • Address customer's issues: improve performance, appearance, and impact on end-user **Education / Experience Requirements** • Bachelor's degree in Engineering with a focus in Plastics, Chemical, Biomedical or Mechanical Engineering preferred • Master's degree in Plastics, Chemical, Biomedical or Mechanical Engineering preferred • Proven balloon development experience • 5 years' experience in Medical Device development or manufacturing **Specialized Skills / Other Requirements** • Working knowledge of manufacturing processes related to medical device manufacturing • Ability to prioritize and work independently as a self-starter with strong proactive work ethics • Experience with design controls, FDA regulation, GMP practices, and QSR requirements Proficient in Microsoft Office, Microsoft Project, Minitab, and Solidworks preferred • Experience with Risk Analyst tools and procedures • Proven track record in Leadership role and utilizing Project Management • Proven track record in product development, design, and working closely with manufacturing • Demonstrated customer relations, problem solving, and product development skills • Ability to influence across boundaries, drive collaboration, and develop product to meet the end users expectations • Must be well-organized, detail-oriented, with excellent oral and written communication skills TRAVEL REQUIRED: 0-15 % The pay range for this position at commencement of employment is expected to be between $109,300- $164,000 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. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. \#LI-LM1 _At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front._ _Teleflex, Inc. 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._ _Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries._ _© 2025 Teleflex Incorporated. All rights reserved._