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Expected Travel: Up to 10% Requisition ID: 8878 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 Teleflex's Arrow line of intra-aortic balloon catheters and balloon pump consoles are the result of years of clinical and engineering expertise from multiple venues that have come together to bring to market innovative cardiac assist products for critically ill patients who require balloon pump support. The Senior Systems Engineer will play a key role in the design, development, testing, and documentation of intra-aortic balloon pump consoles. He or she will collaborate with a diverse team of engineers and have the opportunity to make valuable contributions to a life-saving product. This individual will lead systems engineering-related activities on product development programs, exhibiting outstanding verbal and written communication skills. Principal Responsibilities • Lead systems engineering efforts for a complex, software-driven medical device. • Lead the development and maintenance of product specifications, requirements documents, hazards analysis documents and other technical documentation. • Provide technical leadership for product design, development, integration, testing, and reliability improvements. • Work with subsystem teams, domain subject matter experts, and suppliers in the identification, logging, assessment, and resolution of defects. • Collaborate with a diverse technical team to create, update, and maintain documentation that is or will become part of the product design history file (DHF). • Executes projects with clear objectives and timely deliverables. Understand the goals and contents of development and research projects. • Acts as technical contact in the company to provide recommendations for system verification aspects of projects. • Maintains effective communication with the project manager, and team members on project scope, timelines, and design changes. Education / Experience Requirements • BS in Systems Engineering, Biomedical Engineering, Electrical Engineering, Computer Science, or Mechanical Engineering (or equivalent in a technical/scientific field); MS preferred • 7+ years experience working as a Systems Engineer on product design, development, and/or testing; experience with class II medical device products is preferred Specialized Skills / Other Requirements* • Strong understanding of medica device product design and regulatory processes. • Able to communicate effectively, both verbally and in writing. • Experience with medical device design and development processes that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971. • Strong understanding of system design, electronics, mechanical and software integration. • Knowledge of design of experiments. • Technical understanding of and experience with best-practice product development methodologies #LI-DR1 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®, R sch®, UroLift® and Weck® - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, R sch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.