SALARY - $180,000 - $210,000 per annum + bonus and ESOs.
My client - an industry leading manufacturing of complex medical devices is a hands-on Director of Product Development in order to drive product innovation, research, and development in surgical vision systems.
This role focuses on planning, directing, and executing scalable product development strategies.
The Director of Product Development's role will involve:
Leading and managing product development program of Medical Computer Vision systems.
Direct a multi-disciplinary product development team including electrical, mechanical, software, algorithms, and systems engineering.
Drive rapid new product introductions to position the company as an industry leader in safety and innovation.
Oversee sustaining efforts and manage product performance to maintain quality in the market.
Guide project portfolio execution, ensuring adherence to design controls and maintenance of device design history files.
Develop and maintain the navigation and computer vision technology strategy aligned with the corporate roadmap.
Conduct market analysis to identify new product opportunities and line extensions to keep the company at the forefront of the industry.
Recruit, hire, and train team members to build and maintain a high-performance department.
Ensure quality compliance for products, managing activities such as complaints, CAPA, MDR, NCMR, and other relevant compliance tasks.
Establish policies and procedures to ensure the department complies with all worldwide regulatory standards, including those from the FDA.
Represent the company professionally to regulatory bodies, medical boards, surgeons, and sales teams.
Oversee the development of robust electrical, mechanical, and software data to support technologies developed.
The Director of Product Development will ideally have the following attributes:
Bachelor's degree with 10+ years of relevant business experience or a Master's degree with 7+ years of experience.
Strong expertise in new product introduction, design control processes, and lifecycle management.
Excellent oral and written communication skills.
Proven project management abilities with a track record of delivering results on tight timelines.
Experience in navigating complex issue resolution and problem-solving.
Solid background in highly technical and regulated industries.
Familiarity with FDA 21 CFR, the 510(k) process, and standards like IEC 60601, 62304, 62366.
Proficient in Windows, Microsoft Office, and Microsoft Project.
Ability to travel up to 10-20% of the time.
Strong organizational, technical, and business acumen with the ability to work independently.
For more details about the Director of Product Development role, please apply or reach out to Jack Smillie at jsmillie@pgrec.com for further information.