compatibility and electromagnetic interference testing for our medical device portfolio, ensuring compliance with IEC 60601-1-2.../EMC experience, with at least 2+ years specific to medical devices Working knowledge of IEC 60601-1-2 and its test...
and standards, including IEC 62443, industrial firewalls, and plant-floor LAN/Wi-Fi. Preferred: Experience with Digital Experience..., Prisma Observability: ThousandEyes, Dynatrace, Wireshark OT/Manufacturing: Purdue Model, IEC 62443, industrial firewalls...
communication systems, including IEC 61850. Executing test plans using secondary injection tests and simulating complex control...
Traceability (RTM) IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485 FDA Medical Device Regulations Manufacturing Transfer...
, electrically fast transients, electrostatic discharge, etc. Experience with IEC 60601-1, IEC 60601-2-2 etc. Design for test...
(BMET), or ISO 13485:2016 internal auditor credential. Familiarity with AAMI ST91 and IEC 60601-2-18 standards. Prior...
monitoring, generative AI guardrails). Translate enterprise security, privacy, and regulatory requirements (NIST AI RMF, ISO/IEC...) and AI governance frameworks (NIST AI RMF, ISO/IEC 42001, EU AI Act awareness). Experience working within a cybersecurity or GRC...
in accordance with FDA regulations, ISO 13485, IEC standards, and other applicable regulatory and quality system requirements. The... workflows. Ensure compliance with regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 60601, ISO 14971...
working within standard systems engineering processes, such as MIL-STD-499, EIA-632, IEEE 1220, or IEEE/ISO/IEC 15288...
Compliance: Ensure all electrical designs comply with relevant industry standards such as NEC, IEEE, IEC, API, and ATEX/IECEx...