Senior Biomedical System Engineer
Took part in the installation and commissioning of a three-room proton therapy medical system• Responsible for the system's electrical installation, both power and data, by supervising subcontractor work and ensuring all system specifications are met, including conformity to the National Electrical Code (NEC)• Involved in the deployment of the system's hierarchical control architecture which consisted of top-level servers/workstations, mid-level PLC-based control units, and low-level electronic units• Executed validation and verification testing protocols to satisfy product and regulatory requirements, including 21 CFR 820 (FDA), IEC 60601, ISO 13485, and ISO 9000• Participated in quality assurance (QA) review committees for testing protocols executed by junior engineers• Tasked with anticipating and preventing possible installation difficulties• Trained junior engineers and advised them on their responsibilities• Assisted other senior engineers in their duties, including supervision of other subcontractor works such as equipment rigging and facilities interfacingPerformed maintenance and operations of the system following customer acceptance of installation• Carried out corrective and preventative actions (CAPA)• Resolved system issues during daily operations by performing extensive troubleshooting, often serving as troubleshooting lead• Supervised and monitored the system's clinical operations through SCADA and other supervisory and control software toolsInvolved in continuous product improvement (Six Sigma)• Resolved system's non-clinical shotcomings by designing tools, subsystems and processess to address the shortcomings• Investigated system's clinical shortcomings and submitted to the research and development department (R&D) proposals for resolution• Implemented upgrades validated and/or created by R&DPerformed residual duties• Responsible for site's tool control (Lean)• Responsible for site's lockout/tagout (LOTO) protocol
