teams. Author Human Factors artifacts required for regulatory compliance, specifically IEC 62366, AAMI HE75, FDA Applying... file to support at least one successful medical device FDA approval and IEC 60601-1-6 certification (IEC 62366 TRF...
frameworks (e.g., ISO/IEC 27001/2, NIST 800-53, OWAP, etc.). The successful candidate will be able to work effectively...
, systems, policies, and processes;applying information security and risk-related frameworks (e.g., ISO/IEC 27001/2, NIST 800...
device regulations and standards (e.g., ISO 13485, IEC 62304). Perform software debugging, testing, and validation to ensure... with medical device regulations and standards (e.g., ISO 13485, IEC 62304). Experience with software debugging, testing...
regulations and standards (e.g., ISO 13485, IEC 62304). Perform software debugging, testing, and validation to ensure high... with medical device regulations and standards (e.g., ISO 13485, IEC 62304). Experience with software debugging, testing...
with PLCs (Schneider, IEC 611-31 Programming) SCADA & HMI systems (Wonderware, Ignition) HMI panels & panel PCs (Schneider...
assurance (i.e. ISO/IEC 27001, ISO/IEC 42001), consultation, and training. We have a global network of specialists...
assurance (i.e. ISO/IEC 27001, ISO/IEC 42001), consultation, and training. We have a global network of specialists...
- IEC testing, hardware testing, temperature testing (protocol, results, reports), and design specification review... expertise throughout the product development lifecycle. Conduct IEC 60601 and other certification testing for medical...
and IEC standards, Underwriter’s requirements and applicable building codes preferred. NICET Level II or higher preferred...