High integrity innovative R&D leader with 19 years of experience in the medical device industry space. Specialties include leading and managing cross-functional teams, spearhead multiple critical projects, and design control deliverables, with a broad understanding of scientific, technological, marketing, regulatory, and the clinical aspect of product development Focused on execution an influential leader recognized for In-depth knowledge of disposable and reusable surgical tools, catheters, and guidewire , implants, electronics hardware, and firmware implementation to launch companies and products to achieve goals, drive revenue, ensure operational efficiency.โญ๏ธ ๐๐ง๐ค๐๐ช๐๐ฉ ๐ฟ๐๐๐๐ฃ๐๐ฉ๐๐ค๐ฃ ๐๐ค๐ง ๐พ๐ก๐๐ฃ๐๐๐๐ก ๐๐ฃ๐ ๐๐๐ง๐ ๐๐ฉ๐๐ฃ๐ ๐๐๐๐๐จ โ Convinced management to change the development strategy for Angel and VC funding by performing marketing, technical, and clinical analysis. Worked with a key supplier to develop critical components and establish supplier relationships.โญ๏ธ ๐๐ฃ๐๐ง๐๐๐จ๐ ๐พ๐ค๐ข๐ฅ๐๐ฃ๐ฎ ๐๐๐ซ๐๐ฃ๐ช๐๐จ ๐๐ค๐ง ๐๐ช๐๐ก๐๐ ๐๐๐๐๐ง๐๐ฃ๐ โ Completed product development and market launch by In-depth analysis of competitive products and clinical utility. Provided an alternate proprietary solution and participated in the clinical trial, sales training, and provided product technical advantages for marketing.โญ๏ธ ๐๐๐๐ค๐ฉ๐๐๐ฉ๐ ๐๐ง๐ค๐๐ช๐๐ฉ ๐๐ฅ๐๐๐๐๐๐๐๐ฉ๐๐ค๐ฃ๐จ โ The Go to Leader to negotiate with Scientific Advisory Board and named on 5 patents; identified products, designated development team, implemented clinical exposure training procedures, and influence executive management for resources to launch the product in timely manner.โญ๏ธ ๐๐๐ฃ๐๐๐๐ ๐๐ช๐๐ก๐๐ฉ๐ฎ ๐๐ฃ๐ ๐๐๐๐ช๐ก๐๐ฉ๐ค๐ง๐ฎ ๐พ๐ค๐ฃ๐จ๐ช๐ก๐ฉ๐๐ฃ๐ฉ๐จ โ implement key SOPs for the new product development in compliance with ISO13485 and implemented a regulatory requirements strategy and a quality policy.โญ๏ธ ๐๐ฃ๐ซ๐๐ฃ๐ฉ๐ค๐ง โ Of over 36 issued patents, with several patents pending.
Listed skills include Iso 13485, R&D, Medical Devices, Design Control, and 34 others.
