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...
Factors to integrate usability engineering (IEC 62366) findings into system requirements and risk controls. Support software... (IEC 62304) and electrical (IEC 60601/61010) subsystem teams in ensuring system-level compliance and integration...
factors principles (IEC 62366) to consumable design, including error-proofing, tactile/visual feedback, and ease of loading...
. Preferred Experience supporting FDA 510(k) or De Novo submissions. Familiarity with IEC 60601 (electrical safety), IEC... 62304 (software lifecycle), and IEC 62366 (usability engineering). Experience developing platform architectures intended...
. Responsibilities: Design and develop electrical subsystems for complex medical platforms, ensuring compliance with IEC 60601, EMC/EMI..., and compliance testing Strong working knowledge of IEC 60601, electrical safety, and EMC/EMI compliance Proficiency with schematic...
. Certifications such as CISSP, GICSP, CISA, CISM, CRISC, ISA/IEC 62443, or a Professional Engineer license are preferred. Working... knowledge of adjacent frameworks, including NIST Cybersecurity Framework, NIST SP 800-82, and ISA/IEC 62443, is preferred...
knowledge of industry compliance and regulatory standards, including UL, CSA, SEMI, IEC, ANSI, & IPC Experience leading global...