US-RD
Decomposition: Interpret and decompose medical device standards such as IEC 60601-1-11, ISO 80601-2-70, ISO 80601-2-72. Lead deep...
Decomposition: Interpret and decompose medical device standards such as IEC 60601-1-11, ISO 80601-2-70, ISO 80601-2-72. Lead deep...
, regulatory item master attributes for UDI, ACE, PMA, MDD, IEC) to ensure configured products are realized in Production...
: 21 CFR part 820, ISO 13485, ISO 14971, and IEC 62304 preferred. NO C2C CANDIDATES Interested Candidates...
and regulatory standards such as UL1973, UL9540, NFPA 855, NFPA 70E, NEC, and relevant building and fire codes Understanding of IEC...
and SCADA. Knowledge of utility communication protocols such as IEC61850, OPC, Modbus, DNP3, IEC 101, 104, TCP/IP. Proficiency...
in the practical application of relevant FDA human factors guidance, regulations and standards, including IEC 62366, AAMI...
with relevant industry standards such as IEC and EN standards for medical devices or electromechanical products. Auditor...
environment. Working knowledge of ISO and IEC standards. Strong technical collaboration skills and ability to drive discussions...
development or other regulated industry Familiarity with FDA, ISO, or IEC standards Experience with design verification...
with converter/inverter prototyping, test benches, and debugging. - Experience with standards and compliance (UL, IEC, ISO...