Lead cross-functional engineering team that develops and evaluates the statistical performance of perimeter security sensors for critical pipeline facilities. Developed an innovative assessment and analysis process that became the standard methodology for the customer. Supervised 400% growth (to $2.5M per year) since being promoted to manager. Adapt at building, training, and maintaining a high-performing team. Able to maintain a positive attitude despite customer demands and difficult time constraints. Proficient in Microsoft Office and Microsoft Project.

Led cross-functional engineering team that conducted controlled testing and statistical analysis of bomb detection sensors. Implemented experimental design concepts that reduced required testing time by 50%. Developed simulation for the movement of passengers within mass transit stations. Managed 200% growth (to $1M per year) during time as lead. Developed and executed training for high-profile technology demonstrations in airports and train stations.

Developed sophisticated binary classification model for experimental test data. Developed statistical analysis software that increased analyst efficiency by 75%. Developed training material for statistical analysis of experimental test data. Founding steering committee member of the JHU/APL Statistical Science Community of Practice. Proficient in MATLAB.

In addition to the Program Management Office, I also developed and launched the Systems Engineering Group within Cardiac Assist Research and Development Established the Risk Management Team for complex electro-mechanical medical devices with software Implemented systems engineering concepts to the product development of a new Class II heart-lung machine Technical expert for Design Controls, Requirements, Verification & Validation, and Risk Management Interfaced with Marketing to translate customer needs and business objectives into system-level requirements Knowledge of ISO 13485, FDA QSR, ISO 14971, ISO 62304 and IEC 60601-1

Lead and direct a group of 7 project managers responsible for the management of Class 1 - 3 medical device engineering projects from innovation to retirement. Developed and implemented standardized program management tools and models for use by project teams. Developed and promoted project management career ladder and skill sets within the organization. Utilizes a strategic perspective with holistic approach across the entire project portfolio within the Cardiac Assist and Cardiac Surgery Product Areas. Lead and participate in global initiatives related to project management, product innovation, and organizational optimization. Subject matter expertise on program management best practices for outsourcing engineering activities. Leads Phase 0 efforts from innovation to business case approval for multiple projects.

Lecturer in the Engineering Management and Systems Engineering department. Teach Masters classes in systems engineering, technical management, and project management. Develops all course material, lectures, and assessments. Achieves high scores in course evaluations.

Manage the Systems Engineering team responsible for the development of complex electro-mechanical software driven medical devices. Manage a cross-functional international project to transfer the production of medical device subsystems and components to low cost country suppliers. Technical lead for system/product requirements, verification/validation, requirements traceability, and risk management (ISO 14971). Employing Agile Project Management methodology to meet challenging targets within deadlines. Manage product remediation and enhancement efforts for compliance to ISO 13485 and FDA Part 820. Experience as Subject Matter Expert for FDA and other regulatory inspections.