Focus areas include fatigue and durability testing, in vivo boundary conditions development, computational modeling, nitinol stent design, bench test methods, failure and root cause analyses, standards development, and due diligence assessments.

• Develop and provide feedback for regulatory and device development/testing strategies for medical devices.• Partner with clients to identify options for the non-clinical and clinical evaluation of new and modified medical products.• Provide guidance on communicating information to FDA and other regulatory bodies through formal and informal communication channels.• Specialty areas include: mechanical testing and characterization, device design, root cause and failure analysis, in vivo environment and boundary conditions understanding, durability testing, computational modeling methods.• Regulatory focus includes: preparation of Q-Submissions, Pre-Submissions, IDE and IDE Supplements, PMA and PMA Supplements, OUS and US Regulatory filings.

• Led the program management office within Medtronic’s Aortic Business with responsibility for new product development (NPD) programs and post market projects. • Responsibilities included: chairing the Project Review Committee (PRC); overseeing the leadership and strategic direction of all new product development programs; accountable for the operating program budgets including variable expenses and fixed costs.• Directly led a team of program managers, each of whom was responsible for multiple project core teams and accountable to ensure efficient execution of all projects in the portfolio.• Implemented project management tools to increase the maturity of the PMO organization, improve program predictability, and drive empowerment and accountability across the core teams.• Led the overall cross-functional team responsible for the root cause analysis of the Endurant Evo device failures. Numerous speaking invitations to present the lessons learned from this experience including the Greenberg Stent Summit, UC Davis, and with FDA.• Established the strategy and team structure for Released Product Management (RPM) in the Aortic Business.• Aligned stakeholders and developed governance to align post market project prioritization across all functions, including business unit and operations groups as well as across multiple development and manufacturing sites.• Chaired the Released Product Management Committee (RPMC), with oversight responsibilities for ongoing prioritization and execution of pre and post market projects.• Enabled direct visibility to post market support expenses and resourcing across the P&L, including spend from the R&D, OPC, and product burden line items.

• Served as the interim leader for the R&D function, including all aspects of functional management and program strategic direction.• Accountable for $55M annual R&D budget and allocation of 60 engineers, technicians, managers, and directors.• Increased diversity among the engineering team through focused hiring and driving cultural changes to improve group engagement.• Developed the framework for a sustainable R&D vision and strategic plan, including the implementation of a technology roadmap to guide early research efforts in line with the business strategic plan.• Supported several external business development due diligence efforts while partnering with pipeline marketing to fill out the cadence of product launches.

• Directly led a team of engineering managers and program managers responsible for the development of next generation aortic stent grafts. • Responsibilities included: resource hiring and allocation across project teams; determining and managing project and department annual budgets; influencing and establishing the business strategy for product development and regulatory submissions; executing on the development of next generation products; representing Medtronic to physician customers, senior leadership, regulatory agencies, academic centers, and the local community; integration of business acquisitions including products and resources; collaborations across multiple, global business units.

• Led the simulation and early research group within the R&D department. Represented Medtronic with standards committees (ASTM and ISO) to work on new testing methods specific to stent, stent graft, and catheter delivery system design. Partnered with FDA reviewers to better understand expectations of the review process and to clarify technical aspects of device design and regulatory submissions.

• Created and led a team within the Endovascular R&D organization which was responsible for implementing engineering core technologies for the department, including in vivo imaging analysis, finite element analysis, fatigue and acute bench testing methodologies, NiTi stent processing, and pre-clinical animal studies.