Hamid Mansouri

• Supported full product lifecycle development of neurovascular microcatheters, including requirements, risk management, prototyping, and design verification. • Assisted in regulatory submissions (510(k)/PMA) and documentation to support product clearance. • Employed guide catheters, intermediate catheters, microcatheters, and guidewires for vascular access and device delivery in bench-top testing of endovascular devices. • Developed and executed DV&V plan, protocols, and reports in compliance with ISO and FDA standards. • Developed risk documentation (DFMEA and UFMEA) in collaboration with the team for medical devices. • Experienced in collaborating with manufacturing vendors and suppliers to produce prototypes and optimize the design of our products. • Experienced in designing and executing test procedures on prototypes, coordinating verification tests, analyzing results, and authoring technical reports. • Led weekly meeting with cross-functional teams (Product Management, Regulatory, Quality, Manufacturing) to meet project milestones on time and within budget. • Experienced in collaborating with physicians to gather feedback on clinical product use. • Developed and authored Test Protocols (TPs) and Standard Test Methods (STMs) for catheter verification. • Participated in IPX testing of an electrical detachment handle and documented procedure and results per IEC 60529. • Provided on-site procedural and clinical trial support for Class III neurovascular devices during brain aneurysm implantations. • Ensured compliance with MDR and FDA Design Controls, supporting 510(k) submissions and IDE studies. • Strong knowledge of ISO 7 cleanroom design, EO sterilization processing, and medical-grade wire braiding for catheter manufacturing.

My research focuses on biofluid flow and particle transport in cardiovascular and neurovascular devices, including LVADs, brain aneurysm implants, and stenosis models, using optical imaging to evaluate and optimize device performance. Further details are as follows: • Designed and built a PIV/PTV setup for high-speed optical imaging and studied particle-laden flow dynamics within biological settings (such as LVAD systems, and brain aneurysm models). • Procured materials, optimized instruments, and troubleshot for better setup performance. • Acquired proficiency in high-speed cameras, laser/LED lights, optical lenses, pulse generators, and oscilloscopes. • Achieved refractive-index match using water and SLA printing, introducing a novel approach. • Developed 3D CAD models of the idealized aorta for use in in-vitro and in-silico studies of hemodynamics, resolving optical imaging issues and expanding the results to a generalized population. • Conducted in-vitro and in-silico studies of aorta models grafted with LVADs (under the operational condition of HM III -Abbott Laboratories), optimizing cannula positioning, funded by Medtronic (ERP program). • Collaborated with surgeons, delivering four presentations at APS-DFD and SVIN conferences. • Completed annual safety training to stay compliant with laboratory protocols. • Mentored and supervised students in experiments with the PIV/PTV setup. • Instructed and supervised materials, mechanical testing, and manufacturing labs, covering sample preparation, mechanical characterization (tensile, compression, fatigue, hardness, impact), and hands-on use of equipment such as Instron testing systems, CNC machine, lathe, milling machines, laser cutters and precision metrology tools (Vernier calipers, micrometers, height gauges).

• Conducted image segmentation of brain aneurysms using 3D Slicer. • Deployed endovascular devices in a 3D-printed aneurysm model using a microcatheter and detachment handle. • Performed a particle image velocimetry (PIV) study in aneurysm models treated with 12 different endovascular devices, manufactured by Galaxy Therapeutics, identifying an effective device design. • Conducted PIV flow assessments comparing SEAL™ and WEB™ implants; submitted results as a pre-clinical study to support FDA regulatory approval. • Utilized PIVview software for PIV batch image processing, cross-correlation analysis, and data interpretation. • Applied in-house MATLAB scripts for data processing and statistical analysis. • Collaborated with neurosurgeons, delivering presentations at conferences. • Authored the non-clinical study report and submitted two flow assessment studies to support FDA pre-clinical regulatory approval.