R&D Chemist will be responsible for the design, development, execution and implementation of research and development (R&D) projects. The position will participate in product development from conception to product launch and beyond
Duties and responsibilities
- Maintain open communication and collaborative relationships with all functional departments (Quality, Manufacturing, Marketing, Operations, Clinical, Regulatory, etc.)
- Plan, schedule and initiate research and development projects in areas of technical competence
- Keep up to date knowledge in areas of responsibility, including customer needs, latest technologies and relevant scientific understanding in the area
- Manage all aspects of research and development projects (design control, risk management, design history file, design transfer, etc.)
- Create and foster the formation of patentable ideas and prepare patent applications
- Prepare reports, technical papers, technical presentations to develop reputation and market presence.
- Monitor project schedules and ensuring successful and timely completion of project activities Support Marketing and Operations with technical expertise.
- Bachelor’s degree in Science, Engineering, or related fields with 4+ years’ experience with class II/III medical device R&D, Manufacturing, and/or Quality
- PhD degree in Science, Engineering, or related fields with 0-4 years’ experience with class II/III medical device R&D, Manufacturing, and/or Quality
- Working knowledge of ISO 13485, 21 CFR Part 820 QSR, and Medical Device Directives (MDD)
- Experience managing projects regulated by the FDA / ISO medical device standards
- Good writing and verbal communication skills
- Experience with polymer synthesis, surface chemistry, analytical chemistry
- Experience with medical device coating
- Experience with drug eluting stent or similar products
- Not all inclusive. Employee will perform other duties as assigned.
- Reporting structures may change to meet the ongoing needs of the organization.
- Travel: 10-20%