Brooklyn, New York, United States
Biomedical engineer with startup experience in medical device development, regulatory affairs, ISO 13485 quality systems, and clinical strategy. I recently joined Fortell as a Quality Engineer, where we’re building AI-powered hearing technology that makes conversations clearer for everyone. In this role I support product quality, safety, and continuous improvement as Fortell launches its first product. Previously, I was a co-founder of Relavo, a Class II medical device startup that aimed to reduce infection risk in at-home dialysis. I led clinical development, regulatory strategy, and quality system implementation while working cross-functionally with clinicians, patients, engineers, and regulatory bodies like the FDA.
Fortell is building technology that helps people reconnect with the world around them. Fortell’s AI-powered hearing aids make conversations clearer, not just louder.
Relavo aimed to enable kidney failure patients to live longer and live better by reducing infection risk in home dialysis. The main product, the PeritoneX, was a self-disinfecting connection system to reduce infection risk and enable patients to receive safer care at home. As Director of Regulatory, Quality, and Clinical Affairs, I managed regulatory affairs, the quality management system, and clinical innovation across the product development lifecycle. - Oversaw clinical development across the product lifecycle, from market research and customer discovery to usability testing and human factors engineering activities - Built strategic relationships with clinicians, patients, and caregivers to assess product feature viability and prioritize development based on clinical impact and user needs - Developed and executed regulatory strategy for a Class II medical device, serving as primary contact for 7 FDA meetings - Achieved acceptance into the FDA’s Safer Technologies Program (STeP), strengthening regulatory preparedness and streamlining engagements with the FDA - Implemented and maintained a Quality Management System compliant with ISO 13485 and 21 CFR Part 820 to support early development through transfer to manufacturing
I was an undergraduate research assistant in the Women's Health research group at the Center for Nanomedicine (CNM). I helped implement and analyze experiments investigating the impact of an inflammatory environment during pregnancy on neurological development of pups using a mouse model.
I conducted experiments to test therapeutics for EB using 3D cell culture of human fibroblast cell lines based on a collagen gel contraction assay as well as experiments to analyze therapeutic candidacy for treating skin disorders using Western blots and gel electrophoresis.
I assisted with product development by conducting durability testing to determine the life cycle duration of an affordable cryotherapy device.