Developed medical device concepts through user needs assessment, market analysis, feasibility studies, and specification development, including extensive work on prototypes for balloon catheters and related test methods to ensure alignment with clinical needs and regulatory requirements.Designed electromechanical components and created innovative test methods integrating electromechanical systems to evaluate balloon catheter performance, improving testing accuracy and reproducibility.Enhanced device designs using SolidWorks and 3D printing, achieving a 75% reduction in prototyping time and accelerating product development timelines.Contributed to regulatory strategy by conducting benchtop tests, supporting cleanroom packaging processes, and ensuring compliance with ISO and FDA standards.

Led a cross-functional team to identify unmet clinical needs in plastic surgery, resulting in the design and development of the Nerve Protector device with detailed specifications, test methods, and a robust regulatory strategy.Established a quality management system (QMS) compliant with FDA and ISO 13485 standards, delivering innovative design solutions and facilitating seamless collaboration across R&D, clinical, and regulatory teams.Studied the electromechanical design and prototyping techniques of various medical robots, ensuring compliance with FDA regulations and exploring their applications in advanced surgical systems.

Spearheaded the development of electromechanical implant concepts and motorized tools used in orthopedic surgeries, ensuring compliance with IEC 60601 standards during the design phase.Delivered multiple R&D projects for novel and established medical devices on time and within budget, increasing project completion rates by 20% and enhancing client satisfaction.Conducted feasibility studies, managed design revisions using PDM, and issued Engineering Change Orders (ECOs) to address technical hurdles while maintaining adherence to design timelines.Developed designs to ensure alignment with Design for Manufacturing, Assembly, and Serviceability principles, streamlining production and enhancing device reliability.Mentored junior engineers, boosting team productivity by 30%, and introduced innovative design concepts that reduced prototyping time by 40% and attracted new clients with versatile device systems.Designed and developed medical devices, including implants and instruments, using SolidWorks, ensuring compliance with ASME Y14.5M-2009 standards and conducting tolerance stack-up analyses for optimized assembly and functionality.Gained extensive expertise in human anatomy and surgical procedures, including TSA, TKA, and hip replacements, while leveraging advanced manufacturing processes such as CNC machining, molding, 3D printing, and Wire EDM.Performed comprehensive material evaluations, working with materials like titanium, stainless steel, PEEK, and Radel PPSU, to ensure optimal mechanical properties and biocompatibility for surgical applications.Conducted FEA simulations to evaluate design integrity and reliability, implementing recommendations to refine and improve device performance.