R&D Process Sustaining Engineer II

Date: Aug 19, 2024

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel : Up to 10%

Requisition ID :10834

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 .

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

Provide process engineering support to design and/or process alterations to existing products. Evaluate the impact of proposed changes on existing product manufacturing processes. Also provide engineering support to new product development production line qualification, validation, and launch.

Principal Responsibilities

• Coordinate process change activities.

• Collaborate with internal and external manufacturers of components, sub-assemblies, or finished products.

• Evaluate process changes to existing or new product.

• Provide R&D Process Engineering support for verification, qualification, and validation studies on existing products.

• Support risk management activities (PFMEA) and risk management reviews on existing products.

• Provide R&D Process Engineering support for non-conformance investigations regarding component failures, finished goods failures, and product returns.

• Provide R&D Process Engineering support for customer complaints, including product/record investigation, health risk assessments, identification of CAPA’s, and report generation.

• Support regulatory approvals and responses to regulatory questions for existing products.

• Provide engineering support to new product development production line qualification, validation, and launch.

• Create or revise operator work instructions (process documentation).

• Use analytical problem-solving skills to resolve process problems related to quality, safety, or service.

• Perform and document engineering change orders, yield improvements, and other cost savings efforts.

• 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

• Minimum of 2 years of relevant experience

Specialized Skills / Other Requirements

• Familiarity with various materials and processes, such as extrusion processing, injection molding, machine shop operations, fixtures and tooling, adhesive and thermal bonding and various other processes for catheter fabrication, and design required.

• Experience with design and process risk management documents (DFMEA/PFMEA) is preferred.

• Experience with IQ, OQ, and PQ of medical device manufacturing processes.

• Familiarity with the Agile document control system is preferred.

• Understands various manufacturing and/or assembly processes.

• A knack for independent problem solving of mechanical and/or electrical systems.

• Persistent in achieving success.

• Experience using Minitab to perform data analysis.

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

#LI-NR1

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.

© 2024 Teleflex Incorporated. All rights reserved.