Dallas, Texas, United States
Experienced leader in medical device product development focused on delivering innovative solutions to patients and physician customers. Expertise in R&D new product development, program management, systems and software engineering. Result oriented professional with innovation mindset and strategic thinking combined with excellent analytical, problem solving and change management skills. Experience in global projects and across multiple geographies.
Led multidisciplinary R&D teams for new product development involving hardware, firmware and software for Deep Brain Stimulation (DBS) and Spinal Cord Stimulation (SCS) therapies.
Responsible for Quality Management function of West Virginia state government DHHR project for developing Integrated Eligibility System, to ensure compliance to product quality and client-satisfaction goals.
Served as the leader of Healthcare Business Unit providing software development, healthcare IT application development and hardware design services to global medical device majors and healthcare OEMs. Managed multiple teams on diverse product development projects for different customers. Projects included C-ARM digital X-Ray software development, hardware and software development for hemodialysis system, wireless connectivity solution for surgical devices, and software development for non-invasive ultrasound therapy system.
Established a medical device practice for providing software development services to clients in medical device industry. Managed projects incorporating technology enabled connected health solutions for better care delivery and to improve patient experience.
Built a new Clinical Trial Operations team in India to support global clinical studies in India and Asia Pacific region. Established the structure for providing seamless support remotely for global studies conducted in Australia, Malaysia, Thailand. Managed activities including study startup, site selection, regulatory submission, trial budgeting, vendor management, site contracts and study maintenance. In addition, supported backend operations for clinical studies conducted in Europe and in the US.
Responsible for Product Development and Life Cycle Management of FDA Class-III medical devices. Managed a globally distributed R&D team of engineers in the U.S., China and India for developing software for next generation remote patient monitoring system for implantable cardiac pacemakers. Led development of control software for EP ablation device to treat atrial fibrillation. Managed software verification and validation of safety critical embedded system for next generation implantable pacemaker and for Cardiac Resynchronization Therapy Defibrillator. Experienced functional manager in matrix organization with full responsibility for financial planning, budgeting, resource management and delivering against contracted milestones for multiple projects in parallel. Organizational leadership and people development skills including talent review, succession planning, mentoring and coaching.
Managed a team for developing electrical test software for medical device manufacturing. Responsible for assessing and implementing upgrades to electrical test software used across four production lines between US and Ireland manufacturing facilities. Championed multiple value improvement projects for removing efficiency bottlenecks and improving effectiveness that resulted in net savings with NPV of more than $6M. Applied Six Sigma and LEAN methodologies to realize the savings. Established a system for identifying and prioritizing Value Improvement Projects based on a well-structured cost-benefit model that included quantifying expected benefits and estimating cost based on historical data. Also introduced systems to improve project predictability and productivity.