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Provided the software development management and lead
software systems engineering for medical device startup engaged in the
development of first miniature wearable defibrillator. "Walkman-size"
device is worn by patients subject to possible Sudden Cardiac Death.
Developed the system and software specifications, real-time control
architecture, risk analysis, software-hardware FMECA, and formal acceptance
tests. Wrote software development, safety analysis, and testing guidelines
to fulfill FDA safety regulations for life-sustaining equipment and
to meet applicable medical standards. Analyzed ECG algorithms; designed
user interface; specified error detection and recovery mechanisms. Performed
systems engineering for a variety of technical issues varying from EMI
testing to Y2K issues. Provided software group management, supervised
installation of system network and development tools. Trained technical
staff to develop next version of device; wrote technical specifications
and development plans.
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