America and other regions. Compliance & Quality Systems: Ensure adherence to ISO 13485, EU MDR 2017/745, IEC 60601 standards..., FDA QSR (21 CFR 820), EU MDR 2017/745, IEC 60601, and related standards. Direct experience with Class II/III devices...
substations Hands-on experience with IEC 61850, protection coordination, SCADA point modeling, relays, and substation...
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...
), and relevant national cybersecurity mandates. Certification and readiness for critical assurance frameworks such as ISO/IEC 27001... frameworks such as NIST CSF, COBIT, ISO/IEC 27001, SOC 2, PCI DSS, HIPAA, and SOX. Executive-level communication skills with the...
, CSA, SEMI, IEC, ANSI, IPC);UL/CSA experience preferred. EDUCATION: Bachelor's degree Electrical Engineering (master...
of medical devices, FDA QSR, ISO 13485, and relevant risk and electrical safety standards (ISO 14971, IEC-60601-1/1-2...). Experience with software lifecycle for medical devices (IEC 62304) and Product Life Cycle Management systems. Proven ability...