R&D US Product Management Group

Managed internal Ingestible Sensor and Digital Medicine stability program. Designed stability protocols in compliance with ICH/FDA regulations. Verified and validated shelf life of novel Ingestible Sensor products and qualified new packaging configurations. Performed data analysis using JMP on benchtop test data and automated analysis using custom JMP scripts.Managed change control process to document and implement shelf life extension of commercial product. Successfully interfaced with QA, RA, supply chain, technical operations, and manufacturing to roll out the change.Led Ingestible Sensor failure analysis task force to identify root-cause to sensor stability issues. Designed and executed experiments to identify root-cause, proposed and implemented mitigation strategies, developed in-house failure analysis procedure, and managed weekly technical meetings.Worked with Digital Medicine engineering team to develop next gen sensor tablets. Identified and recommended formulations that balanced manufacturability and product performance.

Taught lab component ofBME 115 Introduction to Biomedical EngineeringBME/MatE 175 Biomaterials

- Plan and implement experimental procedures for lab work- Assist professors with preparing lecture material- Graded quiz and homework assignments

Investigated and identified critical in-use condition for ingestible sensors.Designed an experiment to determine MVTR and impact to shelf life of ingestible sensors. Identified and established testing conditions, test splits, and evaluation criteria.Summarized and reported the results to both technical and non-technical teams via power point and poster board presentation.