ventilators and anesthesia delivery systems. Experience with FDA design controls and IEC software lifecycle processes. Knowledge...
concepts and standards Demonstrated practice in functional safety standards, including IEC 61508, IEC 62061, ISO 13849...
programs such as SOC2, ISO/IEC 27001, PCI-DSS, FedRAMP or control frameworks such as MITRE ATT&CK, NIST 800-53, OWASP...
, ARP4761, DO-178C, DO-254, IEC 13849, IEC 61508, or equivalent Experience with vehicle body systems, such as HMI, doors...
Standards: Ensure the team adheres to relevant regulatory and quality standards (e.g., ISO 13485, IEC 62304), integrating robust...
, ISO 11607, IEC 62366, IEC 62304;cybersecurity expectations;UDI/EUDAMED and labeling requirements (EU MDR Annex I GSPRs...
-53, ISO 27001, IEC 62443, etc.) implementation and governance Program and Project Management experience;expertise...
-53, ISO 27001, IEC 62443, etc.) implementation and governance Program and Project Management experience;expertise...
: CDPSE (ISACA), CISSP-Privacy, ISO/IEC 27701 Lead Implementer or Auditor, NIST Privacy Framework training, GIAC GCCC & GLEG...
) Experience with one or more of: MDR (Medical Device Regulation) ISO 14971 (risk management) ISO 13485 IEC 62304 SaMD...