Research Scientist
Current• Conducting medical device R&D from concept to eventual market under a quality management system (Design Control 21 CFR 820 and ISO 13485)• Designing and executing experiments (in vitro and in vivo) to establish design inputs, and device specifications for eventual FDA submission• Liasing with key opinion leaders (KOLs) and customers (surgeons) to iterate and validate design inputs.• Supporting technology transfer to CMO as a subject matter expert (SME) for device manufacturing (transfer of methods and process validations).• Interfacing with 3rd party vendors/CROs. Experience in vendor communication, management, and achieving deliverables under tight deadlines.• Extensive experience in drafting standard operating procedures, technical reports, and maintaining a Design History File (DHF). • Expertise in: Hydrogel chemistry and characterization, medical device product development (FMEA, 21 CFR 820, and ISO 13485), ISO 10993, in vivo wound models, packaging development, statistics, publication writing