Started a business partnership to provide superior products to the marketplace.Quality control system managementSupply chain managementAccountingEmployee managementProduct design

Key Responsibilities included:-Designed, developed, tested, verified and transferred to production the designs of single use disposable devices for multiple point of care lab-on-a-chip projects, including manually actuated immunoassays and instrumented disposables for PCR and other molecular diagnostics. -Develop product requirements and specifications for FDA regulated devices.-Failure analysis of disposable devices and system failures-Responsible for the activities and outputs according to 13485 and 14971 standards.-Technical expert in the feasibility assessment of client project requirements.-BSL2++ Key contributions included:-Served as design engineer on projects for Fortune 100 companies, US Government, start-ups and academic groups-Contributed to mechanical design of the FDA approved PanNAT molecular diagnostic disposable.-Contributed to design of the manually operated, FDA approved ABORh card for rapid blood typing.-Served as a team member of the Gates Foundation Grand Challenges in Global Health for advancement of a combined immuno-nucleic acid multiplex assay -Supported design transfer activities for commercial scale manufacturing-Contributed to design strategies to promote solutions for economical production and better process capabilities.-Developed and executed cross-discipline platform test plans that included assay assessment, software function and mechanical properties of FDA regulated devices.-Developed software protocols for the interface of instrumentation to biological and mechanical requirements using C# and also proprietary software.-Presented verification outputs to engineers and leadership in a concise and clear manner. Statistical justification of verification strategies and sample sizes based on the necessary confidence level determined by the stakeholders. -Developed and executed DOE's.