formerly Invicta Medical

Now Restera

At Nēsos we developed a wearable system to improve the lives of patients suffering from diseases Rheumatoid Arthritis, Chronic Migraine and Post-partum Depression.My teams managed firmware, software (app, cloud) and electrical development for all clinical devices. We developed a series of research platforms for evaluating the system in conjunction with fMRI, EEG and other research modalities.I handled all of the system, cybersecurity and regulatory requirements (62304, 60601, etc.) for getting our system ready for CE and FDA submission and helped us earn two FDA Breakthrough designations.

Leading a development team in managing ongoing projects. Projects are both new and sustaining, run with both internal and external resources. Following 62304 based software processes, 13485 based risk processes, FDA guidances (process, quality and cybersecurity), etc. to continuously deliver quality product.

Managing development and launch version of the commercial programming platform and all firmware projects. Leveraged highly outsourced teams to beat typical medical device time to market. Heavily involved with regulatory, quality and clinical teams to ensure smooth submissions and product launches.

Developed speech therapy and special education related games and tools. Responsible for complete implementation from design to final product.

Testing product interfaces in a QA role. Answering Tech Support emails. Implementing skins for SoundJam MP the precursor to iTunes.