Experienced in configuraytion and commissioning Process control loops (simple and complex) Application and adherence to IEC 61511...
such as NIST Cybersecurity Framework (CSF) and ISO/IEC 27001, FAIR, PCI-DSS, GDPR, SOC 2, HIPAA Deep understanding of business...
verification and validation activities comply with FDA 21 CFR Part 820, ISO 13485, and IEC 62304. Collaborates with Systems... Comprehensive understanding of FDA QSR, ISO 13485, and IEC 62304 Strong experience with test protocol development, execution...
governance frameworks aligned to standards such as NIST AI RMF, ISO/IEC 42001, and EU AI Act guidance Translate technical... and AI Security frameworks (e.g., GDPR, NIST AI RMF, ISO/IEC 27001, ISO/IEC 42001, OWASP Top 10 for LLMs, MITRE ATLAS...
Protocols (DNP3, Modbus, PG&E Protocol, IEC-61850), 12 years of technical experience with designing and implementing large...
calibration and functional testing in accordance with established procedures and applicable standards (e.g., ISO/IEC 17025.... Working knowledge of ISO/IEC 17025 principles, measurement traceability, and uncertainty. Demonstrated ability to perform...
on plastics (ISO, ASTM, IEC, DIN, etc.). Must be energetic, self-motivated, flexible/adaptable and with good time management...
13485, IEC 60601, or FDA 510(k) processes Experience in machining, additive manufacturing, or test fixture design...
vendors). Oversee testing (stability/safety/compatibility), regulatory and compliance (including IEC/FDA considerations...
of IEC 62304 (Medical device software – software life cycle processes). Experience with medical device systems...