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Work Background
RJuliarConsultingExecutive Consultant
Apr. 2017Greater Los Angeles AreaAn executive consultancy serving medical device organizations. Consult on general management, engineering, product development, operations and quality systems deployment. ➢ Prevented significant potential investor losses by completing a due diligence analysis on a development stage medical device company under client investment consideration through an assessment of the technology, design, market, competition, intellectual property landscape, regulatory compliance, and manufacturing capabilities. ➢ Achieved investment milestones by initiating manufacturing for development stage clients that encompassed contract and in-house strategies through the building of scalable processes and inspection methods as well as operational systems to ensure GMP compliance. ➢ Facilitated the future sale of product / company to established medical device firms through the demonstration of FDA compliance by assisting startup clients in developing QSR compliant operational and design control systems.
J. T. Posey CompanyVP Engineering
Oct. 2011 - Mar. 2017Arcadia, CAA provider of hospital products generating $100 million in annual sales with 800 employees. Directed engineering and product development. LEADERSHIP & VC / INVESTOR PRESENTATIONS
➢ $3 million in COGS saved by driving the operational initiative to move manufacturing from China to Mexico also resulting in a seamless supply of manufactured product
➢ Influenced company sale to private equity under favorable terms in collaboration with other members of the senior management team by developing a business evaluation that best positioned the company, conducting management presentations, and responding to due diligence requests. R&D MANAGEMENT AND PRODUCT DEVELOPMENT
➢ 100% yearly product development pipeline lift realized by instituting an ideation process incorporating innovation techniques, idea filtration methods, and project prioritization that aligned tactics with strategic direction.
➢ Accelerated R&D sales increases and added transparency by introducing metrics to track product development and the ideation process performance.
➢ Three patent applications submitted and six additional invention disclosures, the first filed in more than ten years, by creating an intellectual property strategy and process. ➢ 50% yearly revenue boost from product development achieved by delivering more than 30 new products to market on time and within budget. STRATEGIC PLANNING & BUSINESS DEVELOPMENT
➢ 40% YOY growth in a key product category accomplished by leading the falls management strategic initiative to leverage market position holistically rather than product by product.
➢ Built a series of products to showcase innovative impact protection material with enhanced performance by executing a business development license agreement for the exclusive rights.
Metronom Health (Fjord Ventures)Director of Engineering
Mar. 2010 - Sep. 2011Laguna Hills, CAA small startup company, part of Fjord Venture incubator, producing a continuous glucose monitoring system for use by insulin dependent diabetics based on a novel proprietary transcutaneous sensor design. Recruited at company inception to implement a development plan for a research stage design. ➢ Defined required skills and recruited key company staff for a startup medical device company allowing development to proceed according to the plan, facilitating achievement of investment milestones.
➢ Contributed to early stage funding by building the business tools to explain the technical principles and advantages of startup company technology.
➢ Designed an algorithm architecture to test product performance over the complete physiologic range and translated into software requirements for the glucose determination platform, a key aspect of product performance.
CardioPolymers (Fjord Ventures)Director, Product Development
Apr. 2007 - Oct. 2009Laguna Hills, CAPart of Fjord Venture incubator, manufacturing implants for the treatment of heart failure and cardiac arrhythmias. Engineered the product and the manufacturing process. ➢ Created product development and manufacturing strategies aiding achievement of clinical development plans.
➢ Introduced two polymer materials, each with a unique proprietary applications system, into clinical trials within two years by designing polymer implants and injection systems and managing suppliers for compliant clinical production. ➢ Implemented design control, facilitating the future sale of the product / company.
➢ Developed polymer mechanical testing methodology, in vitro mechanism of action testing and correlation to in vivo functional assessment leading to FDA clearance for clinical trial initiation.
IDM PharmaDirector, Manufacturing & Technology
Jun. 2002 - Mar. 2007Irvine, CAA publicly held startup cell therapy biotechnology company, clinical stage with 150 employees. Held global responsibility in US and France for the development of technology and manufacturing operations associated with GMP manufacture of cellular therapeutic drugs and contract manufacturing of small molecule synthetic drugs for the treatment of various cancers. ➢ 50% cut in processing time and reduced environmental management needed by implementing technology enhancements and manufacturing operations efficiencies including the introduction of automated methods, paradigm shifts, and manufacturing management software tools cleared by the FDA and clinical trials initiated.
➢ Established a global manufacturing strategy / roadmap and business model for autologous cancer vaccines / treatments successfully leading to clinical trials.
➢ Started US product manufacturing including staff recruitment, facility management and, in collaboration with other functional areas, development of manufacturing and quality control systems.
➢ Directed global manufacturing operations including materials and logistics to establish geographic consistency.
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