such as IEEE, SEE, IEC, and engage in trade and industry organizations and benchmarking activities. Establish and maintain...
-functional teams. Candidates should have knowledge of FDA, ISO, and IEC requirements, design controls, and product lifecycle.... Support regulated product development and service activities in accordance with FDA, ISO, and IEC requirements. Maintain...
compatibility and immunity, electrically fast transients, electrostatic discharge, etc. Experience with IEC 60601-1, IEC 60601-2-2...
14971, and applicable IEC standards. Ensure completeness of Design History File (DHF) documentation. Lead and participate...
of assigned product family to help ensure product compliance to applicable regulatory standards (e.g. UL, IEC, ANSI) Creates... specifications and standard requirements (UL, CSA, NOM, CCC and IEC). Create and execute verification & validation plans...
familiarity with applicable regulatory requirements. Working knowledge of IEC 62443. Experience integrating Nozomi Networks...
, IEC 62304, ISO 14971, IEC 60601, DOORS, JIRA, and Cross-Functional Engineering Collaboration. For immediate...
, substation, or utility environments, including familiarity with IEC 62443 standards and hardened or air-gapped systems. Travel...
documents often audited for compliance (NIST 800-82, IEC 62443). Change governance: Scrutinize proposed changes to plant-floor...
, EMS, OMS, ADMS, or industrial control systems. Knowledge of OPC/OPC UA, DNP3, Modbus, or IEC 61850. Experience with PI...