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.

Union: Non Union
Number of vacancies:  1
New or Replacement Position: New
Site:  2400 Skymark Avenue, Mississauga, ON, Canada
Department:  Engineering
Reports to:  Sr. Director, Product Design
Salary Range:  $80,000 to $120,000 annually
Hours: 40 hours per week
Shifts: Monday to Friday
Status: Permanent Full-Time
Closing Date: October 01, 2026

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.

Duties:

• Define user and system/software requirements for the company’s products
• Coordinate work with mechanical and electrical designers, and software developers to ensure that the products meet their intended requirements
• Create and maintain verification and validation plans, protocols, and reports
• Execute verification tests
• Organize and coordinate validation tests
• Assess the product’s reliability and general robustness
• Investigate issues with the product designs and contribute to their resolution
• Write test reports and establish traceability from requirements to verification and validation
• Create and maintain risk management files and usability files
• Organize formal reviews of the design (technical design reviews and phase-gate reviews)
• Coordinate safety and EMC testing of the company’s products
• Obtain feedback from clinical users, including complaints, and translate them into new requirements, feature requests, and design issues
• Maintain the design history file
• Plan, execute and document design change
• Contribute to submissions to regulatory authorities
• Contribute to plan, execute and document preclinical and clinical studies using the company’s products
• Adhere to and enhance the Quality Management System (QMS), including developing and maintaining documentation and training other staff as appropriate

Education:

• B.ASc, B.Sc, or B.Eng degree (biomedical, electrical, mechanical or medical application)
• M.Sc degree or similar is an asset

Experience:

• 4+ years experience designing or testing medical devices
• Experience with formal design and development methodologies, including requirements management, verification and validation, and engineering change control
• Familiarity with working in regulated medical device development environment (ISO 13485)
• Familiarity with risk management for medical devices (ISO 14971)

Skills and Knowledge:

• General knowledge of mechanical engineering concepts
• General knowledge of electrical engineering concepts, electronic instruments, etc.
• General knowledge of information technology
• High Interest in medical technology
• Excellent troubleshooting skills
• Excellent verbal and written communication skills
• Ability to relate to a variety of specialists, including surgeons
• Independent motivation and drive to achieve results
• Ability to work with minimal supervision
• Knowledge of safety standards for medical devices (e.g. IEC 60601) an asset
• Knowledge of regulations in Canada, USA and Europe governing medical devices an asset
• Experience with project planning/management an asset

What We Offer

• Opportunity to work at the forefront of organ transplantation innovation.
• Direct interaction with leading transplant programs across North America.
• Exposure to clinical development, product commercialization, and medical education.
• Collaborative, mission-driven environment focused on improving patient outcomes.
• Competitive salary, benefits, and opportunities for professional growth.