to the engineering community and senior leadership. Experience working within regulated environments (e.g., FDA, IEC 60601...
components including IEC, IEEE, VDE, EN etc. Ability to focus on tasks requiring attention to detail such as design calculations...
support documentation for engineering calculations. Familiarity with design codes and standards such as NESC, IEC, CSA, IEEE...
with medical device standards (e.g., IEC 60601, ISO 13485, ISO 14971). Develop project plans, change requests, identify risks.... Knowledge of FDA 21 CFR Part 820, IEC 60601-1, and related standards. Experience supporting sustaining engineering activities...
, testing standards, and documentation processes Manage field operations for protective relaying, SCADA, and IEC 61850 systems...
, and IEC compliance requirements;effective in coordinating with global manufacturing, sourcing teams, and test laboratories...
regulations and/or standards such as ISO/IEC 27001/2, NIST, Sarbanes-Oxley. · Experience with audit processes and disciplines...
, use, and deploy industry standard protocols – One or more of Modbus, DNP3, IEC-61850, protocol analyzers. IEC-61131-3...
and regular performance reviews. Participate in industry working groups (IEEE, Cigre, IEC) in the creation and application...
to California site (Irvine, CA) -- twice during assignment. Preferred Qualifications Familiarity with IEC 14708 and 45502... Active Implantable standards Familiarity with IEC 60601 Medical Electrical Equipment standards, including laser-specific...