Building AI and Machine Learning powered medical products, navigating through FDA, helping patients.

Advised clients on regulatory strategies for complex medical device and combination product matters to FDA.

- Lead reviewer and acting branch chief for anesthesiology and respiratory devices branch.- Subject Matter Expert (SME) on ventilators, anesthesia gas machines, pulse oximeters, CPAP, oxygen concentrators, nebulizers, and anesthesia brain monitoring devices.- Developed product specific guidance on performance bench testing, human factors and usability study, clinical study protocol, device reliability, Safety Assurance Case, and post market adverse event report analysis.

- Designed and developed custom integrated circuits for space programs such as Mars Rover and satellite payloads.- Led research and development (R&D) efforts in radiation hardened space flight electronic components including digital, analog, mixed signal, and optical photonic integrated circuits.- Subject Matter Expert (SME) on digital, analog, photonic, and fiber optic communication.

- Led development of test hardware and software for satellite flight control modules.

- Analyzed Voice-Over IP communication product requirements and wrote product test documentation and production procedures.