Decisive, action-oriented, and results-focused professional with strong conceptual, technical, interpersonal, and business management skills delivering high quality and commercially viable software products promoting business and product innovation.As an engaged and adaptive leader, my primary challenge is to not only foster the curiosity and creativity of every individual, but to also link the collective energy into a power grid of talent and collaboration generating a field of emerging possibilities. I articulate a clear vision, bring discipline to the processes, stand strong amidst ambiguity and uncertainty, and empower my team to deliver optimum performance rising to exceptional aspirations.My key areas of expertise include, but are not limited to the following: • Outstanding talent in planning and prioritizing multiple parallel and complex projects. • Expert in agile and waterfall management methodologies. • Adept at overseeing all facets of project life cycle, including budgeting, resource planning, procurement, risk management, sprint planning, retrospective analysis, verification, validation, and product launch. • Excellent analytic, communication, and interpersonal skills. • Major strengths in leadership, planning, and problem solving. • Heavily involved in Process Optimization, and Quality Improvement. • Experienced in PMA, IDE, 510-k, and CE mark submission strategies. • Versed in FDA 21 CFR 820.30, IEC-62304, ISO 9001, ISO 14971, and ISO 13485 compliance. • Highly skilled in managing multi-functional teams of 40+. • Possess the ability to be persuasive and clearly articulate points and positions.
Listed skills include Medical Devices, Cross Functional Team Leadership, Testing, Project Management, and 13 others.