Sr. Systems Engineer

Teleflex - Chelmsford, MA

Full-time

Chelmsford, MA

Miscellaneous Manufacturing

About the position

The Senior Systems Engineer at Teleflex will be instrumental in the design, development, testing, and documentation of intra-aortic balloon pump consoles. This role involves leading systems engineering activities for complex, software-driven medical devices, collaborating with a diverse team of engineers, and contributing to life-saving products for critically ill patients. The position requires strong communication skills and the ability to manage technical documentation and project deliverables effectively.

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).
• Execute projects with clear objectives and timely deliverables, understanding the goals and contents of development and research projects.
• Act as technical contact in the company to provide recommendations for system verification aspects of projects.
• Maintain effective communication with the project manager and team members on project scope, timelines, and design changes.

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
• 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