Job Description

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

Qualifications

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

Additional Information

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.

University Health Network

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