Sr. Sustaining Engineer, MDR

Date: Sep 21, 2022

Location: Chelmsford, MA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 6981


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


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

We are seeking a Sr. Sustaining Engineer to join our Cardiac Support R&D group. This position will support MDR remediation of mechanical cardiac support products and accessories. This role will own decisions in handling design and process alterations of existing products as they are remediated. If you are someone who enjoys spending hands-on time in a mechanical lab environment and gaining technical expertise on a wide variety of products, all while working across an organization to achieve goals, we would love to hear from you.

Principal Responsibilities

•    Provide engineering support to design and/or process alterations to existing products
•    Manage engineering activity required to support products through the commercialized life cycle
•    Coordinate Design Change and Process Change activities 
•    Assess proposed Design and Process Changes for the impact to the organization; create evidence based project proposals
•    Develop design inputs and design outputs for changes to existing product
•    Develop new test methods and/or alter existing test methods
•    Provide R&D support for verification, qualification, and validation studies on existing products
•    Support risk management activities and risk management reviews on existing products
•    Provide R&D support for non-conformance investigations regarding component failures, finished goods failures, and product returns.
•    Provide R&D 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.
•    Lead commercialized product change project teams and maintain design history files
•    Ensure design change and process change activities, processes and practices are in compliance with internal quality system requirements.
•    Maintain and supplement design history files that are thorough and accurate for existing product
•    Mentor, train and supervise sustaining engineering technicians
•    Ensure company policies and procedures are followed taking timely corrective action with the help of HR when necessary

Education / Experience Requirements

•    Bachelor’s degree in a relevant field.
•    Six years of relevant experience required.
•    Demonstrated project management skills and ability to coordinate multiple projects simultaneously

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.
•    Knowledge of clinical applications and associated product requirements with the ability to translate these requirements into detailed specifications.



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: 262-439-1894.

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.

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