Design Assurance Engineer II, MDR

Date: Oct 7, 2021

Location: Chelmsford, MA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 4796


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

•    Fulfill design assurance role on new product development (conception to launch) and sustaining projects
•    Complete planning and execution of Design Controls, Risk Management, Test Method Development and Validation, Design Verification/Validation for new and existing products.
•    Support Regulatory Affairs with creating submissions and responding to submission questions.
•    Primary responsibility is New Product Development; secondary responsibility is Sustaining Engineering.
•    Continued support and optimization of DA centric New Product Development deliverables and processes.

Principal Responsibilities

•    Participate and lead New Product Development Phase Reviews and Design Reviews.
•    Partner with R&D to determine and define design inputs, design outputs, and design input/output relationships.
•    Create and support the development and validation of new test methods.
•    Determine and document risks associated with the product (Hazard Analysis, DFMEA, PFMEA, UFMEA).
•    Develop the strategy and manage the execution of design verification and validation.
•    Generate test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing.
•    Develop, execute, and manage First Article inspections.
•    Provide direction to design assurance engineering technicians supporting assigned projects.
•    Support improvement of Design Assurance specific quality system deliverables and processes to increase effectivity and efficiency.
•    Support regulatory approvals and responses to regulatory questions.
•    Support Sustaining Engineering for design and process changes to commercialized product.
•    Support the transfer of new product development projects from development to production. 
•    Support internal and external audits.

Education / Experience Requirements

•    BA/BS in Engineering or physical sciences required.
•    Two years of related experience required.

Specialized Skills / Other Requirements

•    Ability to work independently and with general direction.
•    Ability to define, organize, and manage individual and team based tasks.
•    Provide direction to extended team members.
•    Effective verbal and written communication. 
•    Proficient in technical report writing and review.
•    Interpersonal skills; working in a team and as an individual contributor.
•    Structured and methodical problem-solving approach.
•    Basic understanding of design controls, risk management, statistics, test method validation, and new product development processes.
•    Basic understanding of industry regulations such as ISO13485 and FDA QSR’s.


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.

© 2021 Teleflex Incorporated. All rights reserved.

Nearest Major Market: Boston