Director of Product Development

University Health Network; Mississauga; On-site; CAD 120,000 - 160,000; Full time

Job summary

A leading healthcare organization in Mississauga is seeking a Director of Product Development to drive strategic planning and execution for their medical device portfolio. The successful candidate will have over 10 years of experience in medical device product development, particularly with Class II or III products. Responsibilities include managing cross-functional teams and ensuring compliance with regulatory standards. This is a permanent full-time position located on-site.

Qualifications

• Minimum of 10 years working in medical device product development.
• Direct experience with Class II or Class III medical device products.
• Strong understanding of design controls and risk management.

Responsibilities

• Lead the full product development lifecycle from concept through commercialization.
• Manage cross-functional teams fostering collaboration and innovation.
• Ensure compliance with relevant regulatory standards.

Skills

Crisis Management

Marketing

Public Relations

Fundraising

Media Relations

Strategic Planning

Social Media Management

Team Management

Public Speaking

Writing Skills

Education

Bachelor's degree in a relevant field

Job description

Overview

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

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 510(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

Key Skills

Crisis Management, Marketing, Public Relations, Fundraising, Media Relations, Constant Contact, Strategic Planning, Social Media Management, Team Management, Public Speaking, Wordpress, Writing Skills