Supports development of medical device products with work including writing or verifying specifications, designing new products, test methods, test processes, equipment and specifying raw materials to ensure the concepts and/or prototypes meet their requirements. Typical duties include:
Develop new product concepts and products.
Follow product development cycles via feasibility and design verification testing.
Process Development and Test method validation.
Product related complaints handling and managing technical solutions and resolving complaints.
Support regulatory needs (technical) for new product filings, 510k filing and manage and execute testing requirements needed for global product registrations.
Support Marketing needs (technical) as needed by developing test schedules for competitive products.
Support product launch activities in various markets by providing product related technical training to field staff.
Support clinical cases with field staff during the beta testing phase as required.
Generate intellectual property, write invention disclosures.
May train technicians, and specialists as needed.
Capable of meeting project goals with minimal supervision.
Perform additional responsibilities as assigned.
Bachelor’s Degree in Chemistry, Chemistry Engineering or related four-year degree, preferably in the medical devices industry.
Minimum two (2) years of related work experience in R&D, product development environment, or as a chemist.
Good communication skills.
Design and development cycle of medical devices with focus on chemistry-based implants such as hydrogels, tissues, microspheres and coatings.
Ability to prepare technical documentation, reports, design specifications.
Analytical chemistry knowledge and experience in handling chemotherapeutic drugs.
Knowledge of medical device and technical development.
Working knowledge of materials used in the medical device industry.
Working knowledge of analytical equipment such a GC, GPC, HPLC and USP based dissolution equipment.
Working knowledge or experience in process development of chemistry based implantable devices.
US - United States