Chief Operating Officer
No easy feat to establish, build out, and equip a fully automated, U.S.-based PPE manufacturing operation during the global pandemic—exacerbated by severe supply chain disruptions and labor shortages. I was sought out by several healthcare investors to evolve this new venture so that we could meet skyrocketing PPE demand at national level. Capitalizing on my well-established industry reputation and relationships, I sourced and procured critical PPE equipment and raw materials to establish essential domestic manufacturing capabilities for PPE products and de-risk the USA dependency from Asia supply chain during the pandemic. Focused on bringing essential healthcare industry manufacturing back to the U.S., I conducted deep category research and due diligence, and subsequently secured $1.3M in additional funding after presenting a compelling business case, operational plan, and timeline to investors.While joining the CEO on sales and strategic planning, I serve as the resident sales linchpin during customer presentations and personally field customer inquiries and requests by focusing conversations on value and not price.Another key success factor was obtaining our Emergency Use Authorization (EUA) certification from the FDA within 3 months of launch and expediting our applications to gain quicker in-process approval of FDA 510(k), ISO, and NIOSH certifications with the “gold standard” quality framework.On the operations side, I implemented a fully automated manufacturing process, oversaw the logistics process, and installed organizational processes, workflows, and systems to support the business (ERP, WMS, QMS). In addition, directly sourced, negotiated, and procured equipment/raw materials from Asian manufacturers, expedited freight shipments from Asia, sourced and onboarded key employees, headed and led all regulatory, legal mandates, and CBP requirements for applicable duties and taxes.[About the company: U.S. manufacturer of PPE products].