Mechanical engineering · regulated medical technology
Senior Mechanical Engineer with 10+ years across medical devices, biomedical R&D, microfluidics, simulation, and regulated product development—from product architecture and ISO 13485 design controls through risk management, verification, design transfer, and cross-functional program execution.
U.S. Patent 12,211,209 was granted January 28, 2025; the related work includes two Journal of Biomechanics publications on upper-airway flow and obstructive sleep apnea.
At SCHOTT Minifab, CFD-led design work supported decisions across complex medical-device fluidic programs and contributed to an on-time new-product introduction.
Experience includes controlled development from user needs and design inputs through DFMEA, V&V, engineering change, supplier/manufacturing coordination, and production-ready design transfer.
Experience spans Verathon, Questat, SCHOTT Minifab, Invetech, CSIRO, Barcelona Supercomputing Center, Tehran University of Medical Sciences, and Dentus across Canada, Australia, Spain, and Iran.
Hands-on medical-device and biomedical product development under ISO 13485 design controls, including user needs and design inputs, requirements traceability, DHF/design reviews, engineering change control, DFM/DFMA, verification evidence, and design transfer.
Working understanding of the current FDA QMSR / 21 CFR Part 820 framework and 510(k) pathway expectations, together with ISO 14971 risk management, DFMEA, risk-based design decisions, and V&V planning.
Working familiarity with ISO 10993 biocompatibility and ISO 11607 sterile-barrier packaging; prior IEC 60601-1 medical electrical equipment training/exposure; and familiarity with applicable ASTM medical-device/material test methods and ASME Y14-series drawing and GD&T conventions.
Stage-gate planning, cross-functional technical reviews, supplier coordination, project and technical-risk tracking, schedule visibility, root-cause problem solving, and decision-making across engineering, quality, regulatory, and manufacturing functions.
“Omid's exceptional FEA and fluidic analysis skills consistently delivered robust solutions and production-ready designs.”Rodney Bucknell, Engineering Manager
Selected work
Model patient-specific upper-airway airflow and soft-tissue interaction to investigate obstructive sleep apnea using anatomy derived from dynamic MRI.
Developed the computational and validation workflow connecting imaging-derived geometry, CFD, fluid-structure interaction, and experimental comparison.
Dynamic MRI-derived geometry was segmented to create patient-specific airway models. Airflow was simulated with a k-ω SST turbulence model, FSI coupling was applied at soft-tissue walls, and model predictions were compared with experimental PTV validation data.
The work contributed to U.S. Patent 12,211,209, Prediction and Intervention of Obstructive Sleep Apnoea, granted January 28, 2025 and assigned to CSIRO.
The peer-reviewed study used 3D experimental airway models to validate the numerical approach; the validated simulations linked inhalation-generated vortices and negative pressure to significant pharyngeal narrowing, with the response strongly affected by the inhalation path.
Optimize microfluidic cartridge behavior while accounting for manufacturability, structural performance, verification requirements, and product risk.
Product development engineering across CAD, CFD/FEA, FMEA, prototyping, verification testing, and manufacturability-focused design iteration.
Used CFD/FEA, FMEA, iterative testing, and design-for-manufacture reviews to evaluate fluidic and structural behavior and guide geometry changes.
CFD analysis of complex fluidic systems informed engineering decisions across medical-device programs, and design execution on one program supported an on-time new-product introduction.
Advance mechanical and biomedical systems within a regulated medical-device product-development process while maintaining traceability from user needs and requirements through risk controls, verification evidence, engineering change, and design transfer.
Product and mechanical development from architecture and detailed design through verification and design transfer, working across engineering, quality, regulatory, manufacturing, and supplier interfaces while supporting cross-functional project execution.
Applied ISO 13485 design controls, requirements traceability, ISO 14971 risk management and DFMEA, simulation, tolerance analysis, design reviews, DFM/DFMA, V&V, engineering change control, and design-transfer activities. Regulatory familiarity includes FDA QMSR / 21 CFR Part 820 and the 510(k) pathway; standards familiarity includes ISO 10993, ISO 11607, IEC 60601-1 exposure, and applicable ASTM and ASME engineering standards.
Across medical-device roles, this work has supported progression from concept and risk assessment through verification and design transfer, with robust, production-ready mechanical solutions developed through controlled reviews, evidence, and engineering change.
Medical-device product development under ISO 13485 design controls, including risk-based design, V&V, simulation, tolerance analysis, DFM, controlled engineering change, supplier/manufacturing interfaces, and design transfer; working understanding of current FDA QMSR / 21 CFR Part 820 expectations.
Led design, development, and validation activities for biosensor products, coordinating product decisions across disciplines.
Designed and optimized microfluidic cartridges using CFD/FEA, FMEA, verification testing, and manufacturability-driven iteration; public recommendations cite CFD of complex fluidic systems as important to program decisions and design execution that supported an on-time product introduction.
Developed mechanical and electromechanical assemblies, fixtures, and fluidic systems with attention to thermal, structural, and manufacturing performance.
Applied CFD, FSI, and experimental methods to biomedical engineering research that contributed to a granted U.S. patent and peer-reviewed publications.
Work in numerical simulation, high-performance computing, medical-device prototyping, clinician collaboration, CAD, testing, and product development.
Vol. 37, 2011
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