Manage product development testing proposed for product changes and improvements for the eventual inclusion in the Medicom product offering. Coordinating the testing with third party facilities and/or the manufacturing sites. Ensuring the on-time delivery of results and documentation needed to develop products.
ASSET: Bachelors degree
EXPERIENCE / EXPERIENCE:
REQUIRED: Minimum of 2 years of related work experience in medical device industry with product knowledge
ASSET: Experience in with 510k product regulations and requirements.
Skills, Knowledge & Abilities:
- Basic understanding of design controls
- Knowledge of FDA, ISO and Health Canada regulations
- Strong written and oral communication skills
- Ability to lead multiple projects within aggressive timelines and multiple deliverables
- Technical lead
- Utilize understanding of Design Control Procedures to support projects from concept to launch including prototyping, testing, and scale-up.
- Develop documentation and ensure proper deliverable follow up as per outlined Design Control Standard Operating Procedure.
- Create and maintain technical product specifications for new products or product improvements.
- Provide technical Product Development support to Manufacturing, Customer Service, Regulatory, Quality Assurance, Sales and Marketing and Supply Chain.
Transfer launched product knowledge to Marketing and Regulatory.
- Contribute to strategic sourcing activities
- Contribute to technical testing and analysis of cost reduction alternatives for existing products under general guidance of the Director, Product Innovation and Development.
- Provide and support the technical needs of global sourcing and manufacturing activities towards cost saving initiatives.
- Develop and maintain risk management files as required for medical devices in particular 510k owned products.
- Support risk management analysis and documentation for new products.
- Ensure compliance of the brand and private label product artworks with current product and regulatory requirements and claim verification.
- Perform 510k product complaint trend analysis and present to Manufacturing sites to effectively improve products and complement risk management process.