Manager, Design Assurance

Date: Sep 21, 2022

Location: Chelmsford, MA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 6170

 

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


•    Lead the Design Assurance team supporting new product development (NPD) and sustaining (SE) projects.  Design Assurance Team consists of engineers, technicians, and a technical writer.
•    Staff, develop, and direct team to effectively support execution of Design Controls, Risk Management, Test Method Development and Validation, Design Verification/Validation for NPD and SE projects.
•    Partner with R&D, Regulatory, Process Development, and Operations on organizational/procedural/strategic decisions.
•    Identify, prioritize, and oversee optimization of deliverables and processes.
•    Provide input into corporate strategic initiatives and execute at a site level.
 

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Principal Responsibilities

•    Staff, develop, and manage the Design Assurance team – with strong cross functional interdependencies and coordination.
•    Manage and improve Design Assurance focused Quality Systems – including design controls, risk management, and validation (design, process, and test method).
•    Review and assess New Product Development Phase Reviews and Design Reviews.
•    Provide guidance to teams through technical, system, and execution challenges.
•    Partner with R&D to scope, staff, support, and prioritize NPD and SE projects.
•    Partner with Regulatory to develop, support, and adjust submission strategies.
•    Initiate, prioritize, and lead optimization opportunities to increase effectivity and efficiency.
•    Support the transfer of new product development projects from development to production. 
•    Support internal and external audits – including preparation and direct interaction with auditors.
 

Education / Experience Requirements

•    BA/BS in Engineering or physical sciences required.
•    Ten years of related experience required.
•    Seven years’ experience managing a team.
 

Specialized Skills / Other Requirements

•    Ability to manage a team of engineers, technicians, and a technical writer.
•    Ability to structure and direct teams in alignment with cross functional teams.
•    Establish work direction and supervision of Design Assurance staff.
•    Identify, define, drive, and support strategic initiatives for Design Assurance.
•    Communicate team and project status to senior management.
•    Ability to define, organize, and manage individual and team tasks.
•    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.
•    Foster a positive culture of growth, collaboration, and achievement across the organization.
•    Thorough understanding of design controls, risk management, statistics, test method validation, process validation, and new product development / sustaining processes.
•    Thorough understanding of industry regulations such as ISO13485 and FDA QSR’s.

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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: 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