Principal Electrical Engineer
Provided full life cycle support from feasibility through regulatory approval (IDE, 510(k), De Novo, CE Mark) for multiple generations of extracorporeal CO2 removal (ECCO2R) control systems. • Developed system architecture, select components, and construct prototypes to deliver working systems to software engineers for development.• Maintained system, hardware, and software requirements. Translated change requests to requirements, ensuring completeness, unambiguity, consistency, testability, traceability.• Performed system hardware and software verification. Write and execute test protocols. Write test reports.• Managed subcontractors for schematic capture and layout.• Design for EMC and Electrical Safety compliance.Company-wide Subject Matter Expert for electrical engineering, system engineering, software process, and risk management.• Managed the risk management process. Review hazards analysis, FMEAs, and FTA for adequacy during failure investigations. Update the risk management file when necessary.• Managed the IEC 62304 compliant software process for software releases.• Technical lead for creative problem solving, innovative solutions, and change implementation for complex challenges during development and clinical trials. • Led CAPA, complaint, non-conforming material investigations, perform root cause analysis, implement corrective and preventive action plans as part of the post-market surveillance process.
