with: IEC 62304 - Medical Device Software Lifecycle Processes IEC 82304 - Healthcare Software Safety and Security ISO 13485... - Medical Device Quality Management Systems ISO 14971 - Risk Management for Medical Devices IEC 62366 - Usability Engineering...
with: IEC 62304 - Medical Device Software Lifecycle Processes IEC 82304 - Healthcare Software Safety and Security ISO 13485... - Medical Device Quality Management Systems ISO 14971 - Risk Management for Medical Devices IEC 62366 - Usability Engineering...
such as IEC 62443 or NIST 800-82 is a plus. OEM, platform, or industry training related to controls, networking, or BMS/SCADA...
tools and simulations to model system performance. Ensure compliance with FDA Quality System Regulations, ISO 13485, IEC... 62304, IEC 60601, ISO 14971, and other applicable standards. Lead system-level risk management activities including hazard...
for IEC 60601 safety and EMC Knowledge and experience across engineering disciplines. Familiarity of embedded systems...
or attestations where technical discovery cannot reach. Translate requirements from the EU AI Act, NIST AI RMF, ISO/IEC 42001... AI Act, NIST AI RMF, and ISO/IEC 42001. Background in enterprise security or IT tooling, or experience selling to CISO...
Familiarity with: AREMA Standards APTA Standards FRA Requirements IEC Standards IEEE Standards Experience supporting major...
they need. Experience taking designs through EMC and product safety certification (UL, IEC, FCC, or similar). Experience... like UL/IEC 60730. Clear technical communication, in writing and in person. The ability to net out complicated technical...
security. Solid knowledge and understanding of security regulations and best practices such as SOX, HIPAA, CIS, ISO/IEC 42001...
from requirements to verification in alignment with IEC 62304. Coach product development teams on best practices;act as a spokesperson...