knowledge of IEC 62304 and medical device software lifecycle processes. Hands-on experience with risk management, design...
of industry standards, codes, and regulations, including but not limited to IEC International Electrotechnical Commission IBC...
of regulatory cybersecurity frameworks, specifically generating technical evidence for the EU Cyber Resilience Act (CRA), IEC 62443...
of industry standards, codes, and regulations, including but not limited to IEC International Electrotechnical Commission IBC...
, substation, or utility environments, including familiarity with IEC 62443 standards and hardened or air-gapped systems. Travel...
. Preferred Qualifications Experience working in a regulated industry, such as medical, aerospace, or defense. Knowledge of IEC... Mechanical & Electrical Testing Ex-Vivo Tissue Testing IEC 60601 EMC & Electrical Safety Testing Six Sigma / DRM Cross...
Manager Profile Fluent in IEC 62443 and familiar with adjacent OT / critical infrastructure standards (NERC CIP, NIS2...
in Product Testing and Evaluation Methods (UL/ CSA/NOM/ IEC/ CCC/ ANSI). Product design experience is highly recommended (LVE...
Electrical is preferred. Strong knowledge of NEMA, IEEE, CSA, and IEC standards for control panel design. Ability to manage...
supporting FDA, IEC and ISO standards. This is an onsite position, 5 days per week in Austin, Texas. How You'll Create Impact... Perform software quality review of requirements, design, and deliverables to ensure compliance with FDA, ISO and IEC 62304...