A 29 year engineering career in a regulated environment (FDA, DOD), and safety critical in nature. Experienced engineer and manager with 19 years managing functional teams. Experience in detailed planning with corresponding oversight, risk management, Software V&V, technical design reviews, requirement and other documentation reviews, defect and change management, help line call reviews and analysis, creating and managing budgets, staff allocation and training, legal technical support, and staff morale and motivation.Experience in:• Regulated industries, particularly medical and defense/military (e.g. FDA, CE, DOD). • Risk Management on Drug Delivery Devices and Combination Products• Leading project V&V on real time embedded software systems with wired and wireless communications (e.g. insulin pumps, power management software for the International Space Station.)• Coordinating activities with cross functional teams (e.g. Quality, Risk Management, Software, V&V, Marketing, Engineering, Human Factors, Operations/Manufacturing, Regulatory, Safety, etc.)• Document review and creation (Technical, Plans, Reports, Risk Assessments, etc.)• Scheduling (MS Project) including metrics to enhance predictability.• Develop integrated and cross-functionally linked schedules with corresponding oversight• Establishing and managing budgets• Developing project plans (staffing, process definition/governance, change management, tools selection, etc.)• Working in process driven environments (e.g. IEC-62304, ISO13485, 21CFR820, ISO14971) • Developing applicable procedures to ensure compliance with required design controls.• Technical design reviews and phase gate design reviews, including presentations before applicable review boards.• Defect and Change Management with effort and risk assessments• Experience managing up to 100+ personnel on up to 3 concurrent projects. • Yellow Belt, Six Sigma