Athelas One – Class II Medical Device

A point-of-care, ML-enabled Class II IVD device used for neutropenia monitoring in oncology patients. As Lead Hardware & Firmware Engineer, I owned the full hardware/firmware lifecycle, from architecture and embedded systems to manufacturing scale-up, reliability testing, and regulatory compliance (FDA ISO 9001/13485 and MDSAP), supporting thousands of deployed units across the US and Canada. (All information shown is non-confidential and reflects publicly known capabilities and general engineering responsibilities performed under NDA.)