The Product Development Manager is responsible for new product development and line extension initiatives. Responsibilities include the scoping and identifying product opportunities, creating and shaping products that appeal to identified markets, addressing product portfolio gaps at AMD Medicom. Ensuring the delivery of results and documentation needed to develop new products.
REQUIRED: University degree in engineering or the medical sciences
ASSET: Masters degree or higher
ASSET: Experience in medical device or pharmaceutical industry.
REQUIRED: Minimum of 4 years of related work experience in product development and R&D of medical devices
Knowledge & Skill requirements:
- Basic understanding of design controls
- Knowledge of FDA, ISO and Health Canada regulations for medical devices
- Project management skills
- Strong written and oral communication skills
- Ability to oversee and facilitate the execution of multiple projects within the NPI process and with aggressive timelines
- Product Development Manager:
- Manages and coordinates product development projects within the regulatory requirements
- Enhance department and organization reputation by assessing and implementing new and innovative approaches, and exploring opportunities to add value
- Researches and monitors existing client base and industry developments and identifies potential new product opportunities.
- Conceptualize and research new ideas
- Ensure proper management of projects and adhering to timelines
- Ensure all documentation developed during project life cycle is compliant to Regulatory standards.
- Maintain design history files for proper and timely capturing of design changes and ensuring regulatory readiness consistently.
- Provide support to QA and RA in reference to product specification creation, artwork claims review and complaints handling.
- Support the sales and customer service teams concerning product inquiries.