Design Assurance Engineer, MDR

Date: Jan 14, 2022

Location: Chelmsford, MA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 5298

 

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.

 

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. 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.
 

Principal Responsibilities

•    Participate in 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.
•    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. 
 

Education / Experience Requirements

•    BA/BS in Engineering or physical sciences required.
•    No previous experience required.
 

Specialized Skills / Other Requirements

•    Ability to define, organize, and manage individual tasks.
•    Effective verbal and written communication. 
•    Able to create and review technical documentation
•    Interpersonal skills; working in a team and as an individual contributor.
•    Foster a positive culture of growth, collaboration, and achievement across the organization.
•    Structured and methodical problem-solving approach.
 

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