Biomedical Systems Engineer
Current• Wrote, designed, and tested a custom, breakthrough designation, FDA DeNovo submission of a neuromodulator system• Conducted critical analysis of cytotoxicity, intracutaneous reactivity, and delayed hypersensitivity for a novel hydrogel• Identified and remodeled the housing of a custom medical device assembly to bring it into compliance with IEC 60601 Medical Electrical Equipment Safety Standards• Generated and collected data to improve software failure resilience on a novel device that will offer significant advantages over existing testing methods• Interpreted schematics and integrated-circuit datasheets. Evaluated and ensured compliance to international Medical Electrical Equipment Safety Standards• Trained to perform design and document change control within an ISO 13485 Quality Management System