, ISO 13849, IEC 61508) and regulatory requirements. Prepare and maintain safety documentation, including safety plans...
AI RMF, ISO/IEC 42001, SOC 2, PCI, and applicable retail/data-privacy regulations) into actionable user stories... injection, adversarial inputs) and AI governance frameworks (NIST AI RMF, ISO/IEC 42001, EU AI Act awareness). Experience...
of Science in Chemistry. Certification or demonstrated qualification to conduct ISO/IEC 17025 laboratory assessments.... EDUCATION/CERTIFICATIONS NICE TO HAVE No additional degree is stated. Current ISO/IEC 17025 assessor credentials or documented...
in validation and testing activities supporting FDA, IEC and ISO standards. This is an onsite position, 5 days per week in Austin... compliance with FDA, ISO and IEC 62304 standards. Ensure adherence to quality system processes and design control requirements...
, electrostatic discharge, etc. Experience with IEC 60601-1, IEC 60601-2-2 etc. Design for test, manufacture, and assembly Design...
, particularly with connected or software-enabled medical devices. Familiarity with relevant standards such as IEC 62304 (Software... Lifecycle), IEC 60601, ISO 14971, or similar Experience integrating systems involving mobile applications, wireless...
and Controls drawing experience. Proficiency in standard drafting practices. Knowledge of and experience using IEEE, IEC, ANSI...
and mechanical testing. Medical device/medical equipment experience and knowledge of FDA, IEC, and UL standards preferred....
. Conform to Industry Standards for Medical Device Software (IEC 62304) You will have the opportunity to use state of the art...
(Modbus, Profibus, Foundation Fieldbus, Ethernet/IP) Solid understanding of codes and standards (ISA, IEC, IEEE, API, ASME...