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).