, industrial, or high-tech environments Familiarity with industry standards including ISA, IEC, NFPA 70, ISA 5.1, ISA 88... Knowledge of industrial control system cybersecurity standards, including IEC 62443, and Industry 4.0 technologies Experience...
with IEC 62304 and privacy-preserving techniques such as federated learning. Learn more about our health and wellness...
with relevant regulations, standards and ethical guidelines (e.g., EU AI Act, OECD Principles, NIST AI RMF, ISO/IEC 42001...
security operations. Familiarity with NIST AI RMF, OWASP LLM Top 10, MITRE ATLAS, ISO/IEC 42001, or comparable frameworks...
· Working understanding of FDA, GMP, and ISO 13485 · Working understanding of the following standards: ISO14971, IEC 60601..., IEC 62304, IEC 62366, ISO 10993, and/or ISO 14155 · Systems or clinical engineering experience · Experience with basic...
, healthcare technology, or other highly regulated industries. Knowledge of: FDA Cybersecurity Guidance IEC 62304 ISO 14971...
in a regulated environment such as HIPAA, CLIA, SOX, FDA, ISO 13485, or IEC 62304, ideally in life sciences, diagnostics, or clinical...
medical device standards, including IEC 62304, ISO 14971, ISO 13485, and 21 CFR 820. Evaluate emerging tools, measure...
, GCP, FDA, ISO-13485, and/or IEC-62304). Demonstrated understanding of the Clinical Lab environment and lab processes...
of systems engineering deliverables aligned with ISO/IEC 15288 process areas. You will direct technical architecture development... Apply advanced systems engineering principles across all lifecycle stages in accordance with ISO/IEC 15288 framework areas (Technical...