Quality Engineer 2, Design Assurance **Date:** Apr 11, 2025 **Location:** Chelmsford, MA, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ID** :12072 **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** . **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. • 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. Note: 50% of this job involves direct R&D activities. **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. • Foster a positive culture of growth, collaboration, and achievement across the organization. \#LI-EB1 **Working Conditions / Physical Demands** TRAVEL REQUIRED: 5% WORKING ENVIRONMENT: ☒ Office/Professional ☐ Plant/Manufacturing ☐ Remote/Field ☐ Laboratory _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 Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, 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._ _© 2025 Teleflex Incorporated. All rights reserved._