Ahmed A.

Mechanical Engineer with a decade plus of hands-on experience developing Class II–III medical devices/combination pharmaceutical devices from the earliest concept work all the way through verification, validation, design transfer, and regulatory submission. I’m a licensed Professional Engineer in California and a Certified SolidWorks Expert with experiences in electromechanical systems, catheter technologies, flexible PCBs, and complex assemblies that bring together metals, polymers, adhesives, and precision mechanisms. My background covers every part of the development process: translating standards into requirements, building prototypes, running testing and TMV, designing fixtures, executing risk management, troubleshooting failures, and preparing clear, audit-ready documentation for FDA and EU MDR compliance. I’ve led design efforts, guided cross-functional teams, and worked directly with clinicians and suppliers to ensure designs meet real clinical needs and can be reliably manufactured. I can support your project with expert CAD work, FEA and CFD insights, concept development, DFM, molding and assembly optimization, tolerance analysis, root-cause investigation, and strong technical writing. Whether you need early-stage innovation or late-stage documentation and verification support, I bring a practical, detail-driven approach geared toward getting safe, reliable products into the hands of users. If you’re looking for an engineer who understands both the technical demands and the regulatory expectations of modern medical device development, let’s connect and move your project forward with confidence!