Pr. R&D Process Development Engineer

Date: Apr 18, 2024

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel : Up to 25%

Requisition ID :10229

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

Work as a core team member with cross-functional teams including Marketing, Operations, Design Assurance, Regulatory, and R&D Design to develop medical devices.

Principal Responsibilities

• Lead a small team of engineers to define and effectively execute the process development strategy.

• Represent the process development function on the core team through collaboration, strategy, technical knowledge, and communication.

• Manage the planning, execution, and documentation of all process development & validation activities for new products based on, projected product volume, project timelines, and COGS targets.

• Actively pursue design, process, and equipment improvements to improve process reliability and minimize product manufacturing cost.

• Make process decisions that minimize process issues and resolve those that occur.

• Specify, design, characterize, optimize, and implement manufacturing processes that are capable of meeting design, quality, productivity, and cost requirements.

• Investigate and troubleshoot process issues, determine causes, and implement solutions.

• Develop and implement easy to follow work instructions to produce products that meet requirements.

• Establish project timelines, track progress, manage to the schedule, and communicate project status to management and project leader.

• Lead generation of product development process documentation (e.g., PFMEAs, characterization studies, protocols, reports, MPs, Design Transfer reports, etc.).

• Plan, coordinate, and execute process validations. Transfer validated processes and equipment into production for commercial manufacturing.

• Coordinate with production to produce initial finished goods inventory for new product launches.

• Perform test data analysis.

• Conduct risk analysis, failure analysis, and root cause investigations and report the results.

• Coordinate and execute product development builds.

• Build partnerships and collaborate with others to meet shared objectives.

• Work effectively in a diverse group, respect different ideas, perspectives, and values.

Education / Experience Requirements

• BA/BS in Engineering or physical sciences required.

• 8 years of related experience required.

• Expert level experience working in medical device catheter process development.

• Expertise in process validation (IQ, OQ & PQ), experience with various production processing methods and the product/process development cycle

Specialized Skills / Other Requirements

• MS in Engineering or physical sciences preferred.

• Experience successfully leading a process development team through a catheter development project from concept to commercialization.

• Expert level experience with many of the processes and process aids used in catheter manufacture; polymer laser bonding, hot die polymer bonding, UV adhesive bonding, injection over-molding, catheter reflow, marker band swaging, metal laser bonding, roll-cut, pressure testing, tipping, heat shrink, mandrels, balloon pleat and fold, laser micrometer, optical micrometer, balloon forming, nitinol forming, nitinol laser cutting, braid reinforcement, coil reinforcement, induction heating, hydrophilic coating, silicone coating, packaging, PTFE liner stretch, assembly, metrology, inspection, and fixtures.

• Knowledge of the first principles behind catheter processing.

• Knowledge of poka-yoke tools and implementation.

• Recognized as having a knack for independent problem solving of mechanical and/or electrical systems.

• Persistent in achieving success using a productive and positive approach.

• Experience using Minitab to perform data analysis (including DOE, ANOVA, hypothesis testing, gauge R&R, capability analysis, normality analysis, distribution identification, graphing, etc.)

• Demonstrated project management skills and ability to coordinate multiple projects simultaneously.

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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 is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose.Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, 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.