• Technical background in engineering and scientific research, including design of experiments, data analysis, engineering design, modeling, simulation, and control algorithms.• Experience leveraging model-based design (MBD) for embedded medical devices.• Leadership experience building and leading technical and cross-functional teams, including establishing processes and structures based on an agile/lean framework.• Strong background in human physiology, particularly deep in glucose metabolism (and the pathophysiology associated with diabetes, both type 1 and type 2), as well as hemodynamics.• Thorough understanding of design control, risk assessment and regulatory requirements for medical devices.• Clinical research expertise, including development of clinical research protocols and clinical trial support.• Strong written and oral communications skills. Experience spans from journal papers through supporting documentation for regulatory submissions, from teaching and leading workshops through public speaking.• Experienced coach and mentor to junior staff.• Certified Master Change Manager for the Change Acceleration Process (CAP) and Green Belt trained in Design for Reliability and Manufacturability (Lean Six Sigma).• Interests include: systems engineering, design thinking, modeling and control, data science, lean development methodologies, lean six sigma, model-based design (MBD), change management, innovation, safety engineering, and the application of systems theory, modeling and control to medical, biological, and other complex systems.
Listed skills include Biomedical Engineering, Medical Devices, Matlab, Latex, and 23 others.