., NEC, IEEE, IEC). Knowledge of networking devices and troubleshooting communications. Must have valid driver’s license...
seeking compliance to standards in functional safety and related fields, including IEC 61508, ISO 13849, IEC/EN 62061, UL991..., UL1998, ISO 61511, ISO 21448, UL 4600, IEC 61487, ISO 26262, and other similar standards relevant to systems- and software...
, Ignition) Proficiency creating detailed electrical and fluid schematics in CAD (AutoCAD preferred) Structured Text (IEC 61131...
, IEEE 1453/IEC 61000-4-15, IEC 61000 series, NEC/NFPA 70 or IEC 60364, IEEE C37. Preferred Qualifications PhD/MS...
to align development activities with ISO 14971, IEC 62366, and EU/US Clinical Evaluation standards. Key Responsibilities... (CERs), including alignment with EU MDR and FDA regulatory requirements. · Oversee usability engineering (IEC 62366...
. Familiar with Environmental, Transportation, and Acoustic industry standards such as IEC 60068 series, ISO 7779, ASTM, and ISTA...
teams to ensure Oracle's healthcare solutions align with global medical device standards, including IEC 62304, IEC 82304... to IEC 62304 (software lifecycle processes) and IEC 82304 (healthcare software safety and security). Drive cross-functional...
regulations/standards (IEC 62304, ISO 14971, ISO 13485, 21 CFR 820/11, etc. as applicable) into concrete SDLC policies, SOPs, WIs... and translate healthcare software regulations/standards (IEC 62304, ISO 14971, ISO 13485, 21 CFR 820/11, etc. as applicable...
of scientists to develop fit-for-purpose and robust physicochemical assays (e.g., SEC, IEC, CE, cIEF, PS80, DAR etc.) to support...
for compliance with ISO 13485, IEC 62304, EU MDR and MDSAP requirements. Supports maintenance of the quality management system...