Assurance team to meet the requirements of internal Quality System, including specific requirements of GMPs, FDA QSR, IEC...
of Software development lifecycle · Working knowledge of IEC 62304 · Risk management (ISO 14971) · Sofware as a Service/SaMD... product development · IEC 82304 - Health Software · Understanding of how Agile Software Development practices work...
/proficiency in ISO 9001, ISO 13485, IEC 62304 preferred A combination of training, education, and experience that is equivalent... software languages, such as C, C++, Assembler Advanced knowledge/proficiency in ISO 9001, ISO 13485, IEC 62304...
/edit logic using IEC 61131-3 languages (Ladder, FBD, Structured Text, SFC) with a command of program scan time, timers...
standards such as NEMA, NEC, UL, IEC. - Must know Company procedures and be able to train and supervise others. - Wire panel...
. Proficiency in Human Factors Engineering HE 75 and IEC 62366. A wide degree of creativity and latitude is expected. Excellent...
or International Standards (e.g., UL, CSA, IEC) when required by test requirements. Ability to use oscilloscopes and multi-meters. PC...
and combination products (e.g., FDA/CDER human factors guidance, FDA/CDRH human factors guidance, IEC 62366, HE 75, guidance for OTC...
for wind turbines, such as IEC 61400. *Immigration-related employment benefits, for example visa sponsorship...
Insurance, and 401k matched. SkyePoint Decisions is an established ISO 9001:2015 and ISO/IEC 27001:2013 certified small...