• Supported the scale of the manufacturing process, from small scale process of few thousand per month to a capacity of 4M per month to meet the Covid Rapid PCR testing.• Developed manual and semi-automated manufacturing lines to support the production of the Accula disposable cassette. Design improvement to instrumentation to improve manufacturability.• Designed and built out 7500sqft of dry room space for additional manufacturing lines for Covid Production Ramp up.• Developed scale up methods for producing lyophilized beads in lot sizes up to 300,000 units.• Lead a Capex project to develop web to web (R2R) lateral flow strips. 4 stray lines and 2 lamination lines to produce up to 4 million strips per month.

Lead a group of Engineers and Scientist to improve our manufacturing processes and aid the tech transfer from R&D to Manufacturing.

Continuous improvements to the manufacturing processes for cassette assembly manufacturing, lyophilization of bead reagents, and lateral flow strips. Scale up of automated filling and capping process of sample prep solutions. Build out of new dry room design for manufacturing assembly procedure.

Providing Engineering support to various programs within the company

• As a hands-on Engineer, I am responsible for leading a team of Engineers in the development of the next generation of the Celution Medical Device. Evaluated and establish feasibility of new and innovative technologies that where incorporated in the Celution Device. Optimizing the Sterile disposable set, looking at each component for upgrade to automation. Converting from machined parts to injection mold, and manual assembly to automated assembly. Taking the cost of disposable from $700/set to $475/set.• Responsible for bringing in 3D (FFF) Printing into the Development Group for product development. Significantly reducing time and cost of new designs and improvements to current designs. Successfully transferred the 3D Printing technology to Manufacturing for low volume production components. • Developing new technology to significantly reduce the size (footprint) and cost on the next generation of the Celution Device. This work as led to new patents on the processing of ADSC from adipose tissue and the novel methods for concentrating those cells that allows for large volume processing using a very inexpensive disposable set.• Developed key medical devices; hardware and disposables from concept, to development, developed experimental protocols and summary reports, validations, maintained project documentation for Design History File (Design Control Process), through commercial launch of a Class II medical device for distribution worldwide using the 510K process.• Developed off-shore services for thermoformed and injection molded parts. Worked through 1st article testing, IQ, OQ, and PQ and releasing parts to production for medical grade parts and assemblies.

Responsible for providing on-going support of manufacturing operations for existing and/or new tissue engineered medical products in a cGMP working environment. Support material and process changes and improvements related to the current process and effects on final product. Performing fundamental engineering and design functions such as drawings, calculations, equipment and materials selection and preparation of specifications. Interacting with the Manufacturing Technical Support group on the design, execution and reporting of process related experiments and proposed process changes. Understanding and employing scientific and engineering practices. Providing technical input and support to internal customers on issues of manufacturing equipment and/or processes, process changes, test methods, validation, regulatory compliance, investigations and creation and implementation of corrective actions. Designs and executes experimental studies and engages in prototyping and scale-up to support Product Development Group.

Lead the development of automation for the manufacturing environment, to improve efficiency, cost, labor and customer satisfaction. Provide technical support for current manufacturing processes, and any new projects. Additionally, oversee the validation, calibration and environment control groups.

As a member of the R&D team, worked to take design and improvement projects from initial concept through final design, and design verification to production. Throughout the product development process, worked design and phase reviews, risk analysis, FMEA, and design verification and validation. In a team environment, interface with company management, marketing, purchasing, quality assurance, manufacturing, and other departments and suppliers.Designed and developed innovative plastic injection and electro-mechanical solutions using SolidWorks Design and implement mechanical tests and fixtures Developed test plans, protocols and reports to ensure designs meet product specifications, regulatory requirements and applicable standards. Oversaw design verification testing and troubleshoots technical issues. Collaborate with Manufacturing, Quality, Regulatory and other departments on projects to assure product success Works with vendors and suppliers to ensure components consistently meet design requirements Independently manages and prioritizes projects, tracks progress toward overall goals, and provides periodic updates to management

Responsibilities include new product design, hardware design, software design, scale-up, technology transfer and validation activities. Working with R&D Scientists to develop, automate and optimize the performance of the chemical process using instrument and manufacturing equipment.

• Performed the scale-up and development of two Bioreactor systems for cell culture. Developed a culture system that increased efficiency by 300 percent. Optimized Stir Tank Reactors for cell expansion and protein production and worked on a perfusion system for the Stir Tank Reactors using custom software to monitoring process conditions• Developed Aseptic Tangential Flow filtration system for the removal of cells and debris from the harvested supernatant, with a cost saving of nearly 60K dollars per year. Responsible for the scale-up of ultra-filtration for the concentration of desired protein for down-stream processing.• Optimized the operation of a continuous centrifuge (Centritech Lab II) for sterile concentration of the cells in preparation for cryopreservation. Developed a cell concentration process that resulted in 5 fold improvement over the existing process to be used in cGMP production lab.• Developed software programs for the cell washing system (CytoMate), resulting in an improved viable cell yield. Created a new application for the system to perform sterile serial dilutions of final product.• Developed a cryogenic process for preserving large volumes in flexible bags. Made design changes to improve the process, by optimizing the temperature differentials throughout the bag and the freezing chamber.• Supervised engineering personnel, providing leadership and training.

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• Worked with a small team of Mechanical and Electrical Engineers to develop an innovative digital Gamma Detection Imaging System. This novel medical system replaces the Vacuum Tube imaging systems by being compact and portable.• Initially worked on the high pressure/high temperature reactors that were designed to grow the Cadmium-Zinc-Telluride (CZT) Ingots; used in the digital imaging camera.• Developed the mechanical systems to support the digital-imaging camera. This included the computer/data acquisition systems, thermal management systems and the 4-axis camera arm.• Designed and developed the 360-degree motion chair that docks with the imaging camera to allow a patient to be comfortably positioned during the imaging process.• As lead Mechanical Engineer, activities include designing parts/systems that use a variety of production methods, from machining to plastic injection molding, 3-D Modeling of designs with SolidWorks and optimization with Cosmos (FEA)