Manager, Human Factors
. Have experience with IEC 62366, HE75, FDA Human Factors Guidance's, and/or human factors guidance's from other regulatory authorities...
. Have experience with IEC 62366, HE75, FDA Human Factors Guidance's, and/or human factors guidance's from other regulatory authorities...
Surveillance and Mitigation techniques (for example, Department of Defense SD-22 and SD-26, IEC 62402, or SAE-STD-0016...
Services (DDS), e.g. (RTI Connext, OpenDDS, MQTT, or similar distributed data sharing libraries). Experience with IEC 60601-1..., 60601-1-2, IEC 60601-2-2, IEC 62304, etc. and relevant standards within Medical Devices, or equivalent standards...
and applicable regulations. Organizes and ensures IEC/HA approvals, if applicable, and ensures that the trial is in compliance...
. About US: InterSources Inc. is a Small, Woman, and Minority-Owned Business Enterprise, ISO/IEC 27001, SOC 2 Type 2 certified company...
and data-in-transit, ensuring compliance with FDA cybersecurity requirements, NIST 800-175, FIPS 140-3, and IEC 62443. Define... such as HITRUST & ISO 27001, and IEC 81001-5-1. Ability to work autonomously and proactively seek out product security opportunities...
, including knowledge of standards such as IEC 61010, ISO 13485, ISO 14971. Preferred Experience: Object oriented software...
troubleshooting would be preferred ASQ Certified Calibration Technician (CCT) ISO/IEC 17025 training NIST dimensional metrology...
, IEEE, IEC, NEMA, Telcordia, etc.) and ensuring compliance through proper documentation, testing, and certification support..., IEC, NEMA, Telcordia) Experience with DFMEA, design-to-value, and structured product development processes...
for Hazardous Locations including, but not limited to UL/CSA/IEC/EN 60079 series, UL 1203 and UL 121201 Experience with ordinary... locations standards to include, but not limited to UL/CSA/IEC/EN 60950-1, 62368-1, 61010-1, 60355-1, 60745-1 and 62841...