Director of Product Development
Director of Product Development
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Not Disclosed
Salary Not Disclosed
1 Vacancy
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 Traferoxs 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 companys 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 Traferoxs 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
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
