Systems Developer

Traferox is a medical technology company transforming the field of organ transplantation. Our mission is to improve transplant outcomes and access through innovative preservation and perfusion technologies grounded in rigorous science. We are the creators of the FDA-cleared X°Port Lung Preservation System and pioneers in next generation lung perfusion systems, setting new standards in donor organ care.

Position Summary

The Systems Engineer is responsible for defining, developing, and verifying system and software requirements for innovative medical device products throughout the product development lifecycle. Working closely with mechanical, electrical, and software engineering teams, this role ensures products meet user needs, regulatory requirements, and performance expectations.

The position leads systems engineering activities including requirements management, risk management, verification and validation planning and execution, design reviews, and product reliability assessments. The Systems Engineer is responsible for maintaining design history documentation, supporting regulatory submissions, coordinating safety and EMC testing, and managing design changes. The role also collaborates with clinical users to gather feedback, translate customer needs into product requirements, and support preclinical and clinical studies.

As a key contributor to product quality and compliance, the Systems Engineer helps maintain and enhance the Quality Management System (QMS), ensuring products are developed in accordance with applicable regulatory standards and industry best practices while supporting the successful commercialization of life-saving medical technologies.

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