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.⭐️ 𝙋𝙧𝙤𝙙𝙪𝙘𝙩 𝘿𝙚𝙛𝙞𝙣𝙞𝙩𝙞𝙤𝙣 𝙛𝙤𝙧 𝘾𝙡𝙞𝙣𝙞𝙘𝙖𝙡 𝙖𝙣𝙙 𝙈𝙖𝙧𝙠𝙚𝙩𝙞𝙣𝙜 𝙉𝙚𝙚𝙙𝙨 ─ 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.⭐️ 𝙄𝙣𝙘𝙧𝙚𝙖𝙨𝙚 𝘾𝙤𝙢𝙥𝙖𝙣𝙮 𝙍𝙚𝙫𝙚𝙣𝙪𝙚𝙨 𝙛𝙤𝙧 𝙋𝙪𝙗𝙡𝙞𝙘 𝙊𝙛𝙛𝙚𝙧𝙞𝙣𝙜 ─ 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.⭐️ 𝙉𝙚𝙜𝙤𝙩𝙞𝙖𝙩𝙚 𝙋𝙧𝙤𝙙𝙪𝙘𝙩 𝙎𝙥𝙚𝙘𝙞𝙛𝙞𝙘𝙖𝙩𝙞𝙤𝙣𝙨 ─ 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.⭐️ 𝙈𝙖𝙣𝙖𝙜𝙚𝙙 𝙌𝙪𝙖𝙡𝙞𝙩𝙮 𝙖𝙣𝙙 𝙍𝙚𝙜𝙪𝙡𝙖𝙩𝙤𝙧𝙮 𝘾𝙤𝙣𝙨𝙪𝙡𝙩𝙖𝙣𝙩𝙨 ─ implement key SOPs for the new product development in compliance with ISO13485 and implemented a regulatory requirements strategy and a quality policy.⭐️ 𝙄𝙣𝙫𝙚𝙣𝙩𝙤𝙧 ─ Of over 36 issued patents, with several patents pending.