Comprehensive systems engineering product development and management for cardiovascular medical devices. Product development activities include CA/PA (Corrective and Preventive Action), Product Development Process, Hazard Analysis, FMEA, data analysis/predictive analysis, statistical analysis, complaint analysis, project management (including design and development planning) and external partner development projects. Project work includes FDA remediation, new product development and post-market engineering design changes for the Heart Lung Machine (System 1), CDI 500 Blood Parameter Monitor and the TLink Data Management System. Additionally, I am the SME (Subject Matter Expert) for the Sternal Saw II system.

Co-Founder & CEO, including program manager, business plan & sales and strategy development, chief of finance, Big Data algorithm development.Systems/electrical engineer & manager with broad experience in voice of customer, architecture, algorithm development, analysis, bioinformatics, design, quality and purchasing. Interested in early-stage novel Big Data platform and algorithm approaches.Previously the algorithm team lead/manager for Johnson & Johnson's Ortho Clinical Diagnostic subsidiary where I oversaw a multidisciplinary development team that launched several new devices in the Clinical Chemistry, Donor Screening and Immunohematology businesses using both image analysis and time-based sensor techniques, as well as exploring novel diagnostic and prognostic opportunities in the Bioinformatics area. I have also held various positions at Hamilton Sundstrand (a United Technologies company) and Jabil Circuit.Specialties include: Algorithm development, Big Data, pricing, bioinformatics, competitive strategy, finance, capital budgeting, game theory, monte-carlo simulations/Crystal Ball, Matlab, Excel, multi-variate analysis, electrical engineering, design engineering, medical devices, diagnostics, prognostics, aerospace, automotive

Lead engineering development teams in the immunohematology, donor screening, clinical chemistry and bioinformatics departments. Develop both short and long-term strategies pertinent to bioinformatics and novel medical content delivery, including Matlab, software algorithm, database infrastructure and architecture, bioinformatics engineering. Achievements included:- Lead a team to analyze patterns in immunohematology image outputs and develop sophisticated algorithms to compute agglutination and error-checking. - Lead a cross-functional team with the Marketing department to define from a customer’s perspective what throughput enhancements would drive incremental business results for OCD.- Managed a global, strategic business partner for a bioinformatics development project functioning as the program manager.- Developed short and long-term strategy for a new Bioinformatics department, ultimately leading to the creation of the new department with staff in multiple domestic R&D locations.- Self-initiated two new software engineering development projects to narrow potential biomarker opportunities and to optimize biomarker parameters.- Led the donor screening divisions systems engineering activities for a new automated fluid pipetter project, utilizing ELISA technology.- Designed feasibility studies and test cases for program development and wrote design verification test plans and reports, submitting these documents as part of an FDA product submission (traditional 510k).- Led a Johnson & Johnson corporate-wide initiative to implement Matlab on a High Performance Computing (HPC, supercomputer) cluster.- Developed a Matlab training course for company-wide use (including teaching associated live training), which led to a consistent algorithmic design environment that saved an average of four months development time per project.- Conducted sig-sigma value-stream analyses at customer donor screening labs.

Senior Systems Analysis Engineer, including Matlab, software algorithm, database infrastructure and architecture, bioinformatics engineering

Generate innovative database designs & implement for quality and operations groups. Design new electrical circuit board subsystems & end-of-line test equipment for commercial & military airplanes. Negotiate long-term agreements for electronic parts procurement. Design plane simulator circuitry for the EuroFighter plane while working abroad in Germany.

Engineering technician intern with responsibilities for constructing end-of-line electronic test fixtures and troubleshooting problems in conjunction with test fixtures and circuit boards to increase reliability.