QUALIFICATIONS 7+ years of experience or equivalent experience in Medical Device Design control for software product and the application of ISO14971, 21CFR820, 21CFR11, MDDS, ISO13485, IEC62304, IEC62366, IEC60601, IEC60812, and IEC 82304. Typically, employees sit comfortably to do their work, interspersed by brief periods of standing, walking, bending carrying papers and books, and extensive periods requiring the use of computer terminals to accomplish work objectives.