System Developer Jobs

Traferox creates, manufactures and commercializes products used to transplant solid organs (lungs, heart, liver, kidneys, pancreas).These products employ technologies invented by the transplant surgeons at the University Health Network (UHN). Traferox currently sells the TorEx Lung Perfusion System and the XPort Lung Transport Device.Traferox Technologies is committed to improving the outcomes of organ transplants and to save patients’ lives.

Location:

The work will be performed in the company’s place of work at 3505 Laird Rd. Unit 16, Mississauga, Ontario L5L 5Y7.Minimal travel (<10%) is expected.

Reports to:

VP Engineering

Responsibilities:

• Organize project meetings and milestone reviews
• Organize, coordinate, and execute verification and validation tests
• Contribute to plan, execute and document preclinical and clinical studies using the company’s products
• Define system architectures and specifications
• Obtain feedback from clinical users, including complaints, and translate them into new requirements, feature requests, and design issues
• Track progress on the project, keep all stakeholder informed, and track actions items and issues
• Create and maintain risk management files and usability files
• Plan, execute and document design change
• Investigate issues with the product designs and contribute to their resolution
• Create and maintain verification and validation strategy, plans, and protocols
• Contribute to submissions to regulatory authorities
• Write test reports and establish traceability from requirements to verification and validation
• Coordinate with mechanical and electrical designers and software developers to ensure that the products meet requirements
• Define user and system requirements for the company’s products

Education:

• Bachelor of Engineering (Biomedical, Electrical, or Mechanical)
• Masters in Science or similar degree is an asset

Experience:

• Familiarity with working in regulated medical device development environment (ISO 13485)
• Familiarity with risk management for medical devices (ISO 14971)
• 2+ year experience with biomedical technology (this may include academic experience)
• Experience with formal design and development methodologies, including requirements management, verification and validation, and engineering change control

Skills and Knowledge:

• Independent motivation and drive to achieve results
• Excellent verbal and written communication skills
• High interest in medical technology
• Ability to relate to a variety of specialists, including researchers and surgeons
• Ability to work with minimal supervision
• Experience with project planning/management
• General knowledge of mechanical engineering concepts
• General knowledge of electrical engineering concepts, electronic instruments, etc.
• Excellent troubleshooting skills

Additional desired qualifications:

• Ability to use scripting programming language (Python or Matlab)
• Knowledge of regulations in Canada, USA and Europe governing medical devices
• Knowledge of safety standards for medical devices (e.g. IEC 60601)