Company Description About Traferox: 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.

Job Description Union: Non-Union

Number of vacancies: 1

Location: 2400 Skymark Ave, Mississauga, ON

Department: Engineering

Reports to: President

Status: Permanent Full-time

Position Summary The Director of Product Development will lead the strategic planning and execution of all product development activities across Traferox's medical device portfolio. This senior leadership role is responsible for transforming clinical and market needs into innovative, compliant, and manufacturable products. The ideal candidate combines deep technical expertise, strong regulatory knowledge, and a proven track record of bringing complex medical devices from concept through commercialization.

Location: The work will be performed in the company’s place of work at 2400 Skymark Ave, Mississauga, Ontario. Minimal travel (<10%) is expected.

Key Responsibilities

• Lead the full product development lifecycle, from concept through commercialization, ensuring alignment with Traferox's strategic objectives.
• Manage cross-functional teams, including R&D, systems engineering, industrial design, and human factors, fostering collaboration and innovation.
• Ensure compliance with relevant regulatory standards, including ISO 13485, FDA 21 CFR Part 820, and EU MDR.
• Collaborate with internal stakeholders, such as Clinical, QA/RA, Manufacturing, and Supply Chain, to align development activities with business and regulatory goals.
• Oversee project management, including risk assessment, timeline development, budget management, and resource allocation.
• Drive continuous improvement, championing design controls and process enhancements to optimize product development efficiency and quality.
• Represent Traferox in technical discussions with strategic partners, suppliers, and regulatory bodies, maintaining strong external relationships.

Qualifications

• Minimum of 10 years working in medical device product development, with a proven track record of leading complex electromechanical system projects.
• Direct experience leading the development of Class II or Class III medical device products that have been successfully brought to market through the FDA 501(k) or PMA regulatory pathways.
• Must have led efforts involving design, development, verification/validation and submission processes aligned with FDA regulatory expectations.
• Regulatory Knowledge: Strong understanding of design controls, risk management (ISO 14971), and usability engineering (IEC 62366).
• Leadership Skills: Demonstrated ability to lead multidisciplinary teams, manage cross-functional projects, and drive strategic initiatives.
• Communication: Excellent verbal and written communication skills, with the ability to effectively convey complex technical information to diverse audiences.
• Excellent verbal and written communication skills

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