Sr. Systems Engineer

Sr. Systems Engineer

Date: Dec 16, 2024

Location: Chelmsford, MA, US

Company: Teleflex

Expected Travel : None

Requisition ID :11550

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 ~~~ .

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 medical 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

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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, 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: ~~~ or ~~~.

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.

© 2024 Teleflex Incorporated. All rights reserved.