Engineering Project Manager

2 days ago

Mississauga Ontario, Peel region, Canada Traferox Technologies Inc. Full time

Company Profile:

Traferox creates, manufactures and commercializes products used to transplant solid organs,

employing technologies invented by the surgeon team of the University Health Network (UHN), with the goal to increase availability of donor organs, improve surgical outcomes and save patients’ lives. Traferox’s products include the TorEx Lung Perfusion System and the X°Port Lung Transport Device.


Responsibilities:

The Engineering Project Manager is generally responsible for projects to research and develop new applications of the company’s organ perfusion technology, from initial concept to translation into the clinic and eventual commercialization. They interact with the R&D team to bring projects to a successful conclusion. They are also take the lead role in system engineering for the projects. The Engineering Project Manager reports to the Vice-President of Engineering. Specific responsibilities include:

  • Define user and system requirements for the company’s product.
  • Define the high-level architecture of products in order to satisfy user requirements and business needs.
  • Create and implement project plans
  • Lead projects to design, prototype and test new medical device products.
  • Coordinate work with mechanical designers, electrical engineers and software developers to ensure that the products meet their intended requirements.
  • Plan and execute proof-of-concept experiments to demonstrate new designs before they are incorporated into product development.
  • Define the verification and validation strategy and create verification and validation plans, including timelines and resource planning.
  • Coordinate verification and validation tests and conduct tests when appropriate.
  • 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.
  • Report to management on the status of projects.
  • Contribute to submissions to regulatory authorities.
  • Contribute to plan, execute and document preclinical and clinical studies using the company’s products.


Education and Experience :

  • Bachelor of Engineering (Biomedical, Electrical, or Mechanical)
  • Masters in Science or similar degree is an asset
  • 5+ year experience with medical device engineering
  • Experience with formal design and development methodologies, including requirements management, verification and validation, and engineering change control
  • Experience with managing engineering projects
  • Experience with working in regulated medical device development environment (ISO 13485)
  • Experience with risk management for medical devices (ISO 14971)
  • Experience with obtaining FDA regulatory clearance for medical devices (510k or PMA)


Skills and Knowledge Required

  • 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 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


Additional Desired Qualifications:

  • Knowledge of safety standards for medical devices (e.g. IEC 60601)
  • Knowledge of human anatomy and physiology
  • Knowledge of regulations in Canada, USA and Europe governing medical devices



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