Our manufacturing and commercialization expertise has been honed by 25+ years of experience in engineering, operations, and leadership roles for Class I, II, and III medical device companies around the world.
More recently, in support of a US government initiative to accelerate the manufacturing of diagnostic products (particularly during the COVID pandemic), we traveled to numerous companies to identify the gap between innovative ideas and the skills needed for large-scale manufacturing.
Over these decades, we have explored multiple tools and techniques to improve profits, time to market, and capacity, building an arsenal of insights and methodologies that we now apply to companies of all sizes and across all industries.
In 2022, we built our current offices and a cutting-edge manufacturing facility in Corona, California, where we can partner with startup and growth-stage companies to innovate, build, and bring products to market.
Aaron is an operations leader experienced in results-focused development, deployment, and cross functional alignment of business processes and metrics. He has demonstrated success in high-, medium-, and low-volume manufacturing settings for Class I, II, and III medical devices, leading cross-functional teams and helping multinational companies save tens of millions of dollars annually. He has been a principal engineer and a manager, director, and senior director in global manufacturing. Aaron earned a BS and an MS in Mechanical Engineering from California State University, Fullerton.
Kevin is an experienced engineering leader in medical device manufacturing. He provides manufacturing engineering, process validation, and leadership development to solve systemic problems and improve productivity. His areas of expertise include document and change control, EU MDR remediation, US FDA QMS Remediation, due diligence and design remediation, and production scaleup for Class I, II, and III medical device products and diagnostics, including recent work with numerous COVID-19 IVD companies. Kevin earned a BS in Mechanical Engineering, BS in Mathematics, and MBA from UC Irvine.
Operational Velocity
109 N Maple St, Unit J
Corona, CA 92878-3298
951 475 7038 | 949 445 0532
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