Sandi has over 17 years’ experience in R&D and engineering within the academic and the medical device industries. Sandi is skilled in Product Development phases spanning from preclinical feasibility and bench performance testing to global commercialization. As a Materials Scientist, Sandi has researched polymers, composite materials and nanomaterials, in addition to studying surface and interface effects on material performance through mechanical and thermomechanical testing.

Sandi’s additional expertise includes initiating new product ideas for unmet needs, design verification/validation and testing for claim substantiation. She received her Master’s and Doctoral Degrees in Mechanical Engineering from Northwestern University (Illinois) and her Bachelor’s Degree in Physics from Chulalongkorn University (Thailand).

CORE COMPETENCIES

• Product development management, test method development, R&D budget and strategy, bench performance testing and data support for claim substantiation
• Patent filing and patent holding for innovative products
• Study management and oversight of preclinical bench testing and clinical studies, including collaboration with dental professionals
• Root cause investigation of cardiovascular and dental prophylactic devices
• Support of FDA audit and meeting preparation
• Author of R&D technical documents, test reports, standard test method procedures, regulatory submissions and peer-reviewed journal publications

RECENT PROJECTS

• Led documentation of a comprehensive R&D technical report for the root cause investigation regarding an endovascular stent graft and supported FDA meeting and audit preparations
• Headed strategic development of a sustainable product line as well as the effort for evaluating sustainable materials including bio-based, biodegradable and compostable plastics
• Developed a new test method to assess the efficacy of a wide range of dental products for claim substantiation, then published and presented the studies in scientific journals and conferences