Description
SUMMARY Medical device management professional (MS, MBA) with leadership experience in Stage Gate Product Development Process (PDP), Class I, II and III devices, Systems Engineering, Design Control, Quality Systems Requirements, clinically relevant strategic roadmap creation, capital equipment, IP portfolio management, market-driven technology development, product development, business development, project management, drug/device combination products, materials research (metals, alloys, polymers, biomaterials), design, electro-mechanical systems engineering, strategic planning, team building and people development. * Highly successful track record of accomplishments in the medical device (orthopedics, cardiovascular, peripheral vascular, neurovascular and heart valve) industry. * Successful track record in new product development (NPD), and integration of science and technology into business processes. * A passionate and energetic leader with an ability to effectively coach, mentor, resolve conflict and provide leadership to personnel, and perform multiple tasks in an environment of changing priorities. * A hands-on problem solver with strong analytical skills, business and strategic acumen. * Experience with embedded software in electro-mechanical systems (Automated External Defibrillators) and software-controlled devices. * Strength in execution and implementation of projects on time and within budget. Proven expertise in leading cross-functional teams in a data-driven culture that embraces the principles of continuous improvement and design for manufacturability (DFM). * Extensive experience in design, development and testing balloons, dilation catheters, access sheaths, dilators and delivery system components (guide wires, introducers, obturators). * Strong background in cGMP (21CFR 820), Quality Systems Requirements (ISO 9001 & 13485), Risk Management (ISO 14971, EN 60601) and European Medical Device Requirements (Council Directive 93/42/EEC). * Experience in Process Excellence tools (Six Sigma, DMAIC, DFSS, Lean Manufacturing, and Value Stream Mapping).
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