Medical manager Offres d'emploi - Haldimand, ON

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 a senior member of the R&D team and is responsible for leading 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 work with the R&D team to bring projects to a successful conclusion.  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.
• Manage issues identified in tests and coordinate with designers to ensure timely resolution.
• 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 :

Skills and Knowledge Required

Additional Desired Qualifications :