Medical Device Systems Engineer — Regulated & Impactful

University Health Network; Mississauga; Presencial; CAD 80.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary

Benefits package

Professional growth opportunities

Descripción de la vacante

Traferox is a medical technology company advancing organ transplantation through innovative preservation and perfusion technologies. The Systems Engineer will define, develop, and verify system and software requirements across the product lifecycle, collaborating with mechanical, electrical, and software teams to ensure regulatory compliance and performance.

The role leads requirements management, risk management, V&V planning, design reviews, and product reliability assessments, while

Formación

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

Responsabilidades

• 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

Conocimientos

Requirements management

V&V

Systems engineering

Regulatory compliance

Cross-functional collaboration

Educación

B.ASc/B.Sc/B.Eng in biomedical/electrical/mechanical

M.Sc degree asset

Descripción del empleo

Traferox is a medical technology company advancing organ transplantation through innovative preservation and perfusion technologies. The Systems Engineer will define, develop, and verify system and software requirements across the product lifecycle, collaborating with mechanical, electrical, and software teams to ensure regulatory compliance and performance.

The role leads requirements management, risk management, V&V planning, design reviews, and product reliability assessments, while