and concentration concerns) and apply AI vendor risk frameworks (NIST AI RMF, ISO/IEC 42001) to AI-enabled products and services in the... and methodologies (e.g., Shared Assessments SIG, NIST SP 800-161, ISO/IEC 27036) and the underlying security and privacy regulatory...
CFR Part 820.30, ISO13485) preferred. Knowledge of Medical Device/FDA Regulated Industry and compliance with IEC-60601..., 62304, ISO14971, IEC 62366, EU MDR preferred. Experience with requirements management (including technical content reviews...
Level 3 and ISO 9001: 2015, ISO/IEC 20000-1:2011, ISO/IEC 27001:2013, ISO 14001 Certified Small Disadvantaged Woman Owned...
standards (IEC 61508, ISO 13849, ISO 26262) and experience preparing algorithms for third-party certification - Familiarity...
. Experience with safety-critical software (ISO 26262, IEC 61508). Familiarity with ML-based perception pipelines. Open-source...
- Experience with safety-certifiable product development (ISO 13482, IEC 61508, or comparable functional safety standards...
equipment or regulated product development. Experience with IEC 60601, EMC testing, safety testing, or medical device design...
like Modbus, DNP3, and IEC 61850;and troubleshoot and maintain existing EMS for operating projects by resolving connectivity...
, task analysis, use-related risk analysis, and usability testing. Knowledge of IEC 62366-1, FDA Human Factors Guidance...
vehicles, drones, or industrial automation. Experience with safety-critical software (ISO 26262, IEC 61508). Familiarity...