Lead the strategic planning and execution of all projects within a medical device startup, advancing the primary portfolios of carotid artery stenting (w/ integrated embolic protection) and peripheral mechanical thrombectomy devices. Define strategic objectives, align resources, and drive advancements across multiple projects simultaneously. Craft timelines, milestones, and deliverables in alignment with organizational goals and unmet clinical needs. Advance projects in a high-speed, dynamic and small-group environment. Drive deliverables for FDA IDE and PMA activities, supporting human and animal clinical studies, and advance commercialization activities of legacy products. Reporting to the company President / COO, act as key liaison between internal stakeholders, physician inputs, and company needs. Provide leadership and mentorship to project teams, fostering professional growth and development.

Managed the initiation and development of multiple projects within Penumbra’s electromechanical thrombectomy portfolio. Developed product portfolio strategy, managing employees, project resources, and timelines with consideration of market forces, regulatory environment, and technical needs. Directly interacted with physicians, obtaining user inputs, demoing products, and establishing relationships within the neurovascular, peripheral vascular, & pulmonary vasculature anatomies. Contributed to clinical study execution, drafted regulatory responses, & prepared design control strategies to mitigate risk and improve time to market. Visited hospitals to understand unmet market needs and train engineers in a clinical environment.Organized animal studies and design control strategies across multiple Penumbra project portfolios, evaluating devices in vivo. Worked directly with CMO and CSO to prepare evaluations of competitive devices and resultant strategies. Provided IP assessments for patent strategy and filing. Directed gap analyses of medical device and engineering standards. Engaged new vendors to provide second-sources for services and materials to mitigate supply-chain risk. Managed relationships with outside contract manufacturers and consultants to support R&D needs. Served as technical liaison between multiple projects, advising catheter, electromechanical, benchtop model, & test method development.Expanded existing engineering roles to include electrical engineering and embedded software engineering, augmenting existing mechanical engineering core competency. Established expanded employee titles & job descriptions, maturing employee development and career tracks.Chosen for Penumbra’s Leadership Roundtable training in 2021, improving managerial skills. Established inaugural employee development program, providing resources for employees’ continual improvement and growth. Reinitiated summer internship program post-COVID.

Core Team Lead for covered nitinol biliary drainage stent, managing a cross-functional team from Concept to First-In-Human & commercial launch. Create and manage project budgets & timelines, develop specifications, manage technical resources and talent, perform physician Focus Groups with Key Opinion Leaders in the field. Provide managerial leadership and technical & project expertise for multiple projects simultaneously across different anatomical spaces. People manager with seven direct reports.Previously Project Lead of the Beacon EUS Access Device, a directable nitinol needle system for use in interventional biliary procedures with Endoscopic Ultrasound. Led project from initial concept to successful human clinical use and commercialization. Skilled in creating project life cycle plans per ISO 13485, user needs determination, risk assessment per ISO 14971, packaging, ISO 10993 biocompatibility, sterilization validation, Design for Reliable Manufacturing (DRM), verification & validation testing, process qualification, manufacturing transfer, clinical readiness, and commercialization. Contributor for FDA 510(k) and EU CE Mark submissions and international launch strategies. Creator of novel IP and contributor to patent strategy. Member of due diligence teams to acquire / license competitive and emerging technologies.Medtronic Intern Manager of the Year, 2017. Member of Medtronic Global Innovation Fellowship. Site lead of Summer R&D internship program since 2012. Selected for Leadership Development Program in 2013 and 2019. Site lead for Medtronic’s Women in Science & Engineering initiative.

Project Lead developing a nitinol biliary catheter system, managing a cross-functional team from Concept to First-In-Human. Create timelines, develop specifications, manage technical requirements, perform physician Focus Groups with Key Opinion Leaders in the field. Identify and develop talented individuals into core technical members. Provide technical and project expertise for upcoming projects within the biliary portfolio of devices.Previously Project and Technical Lead for esophageal cell collection device and radiofrequency ablation (RFA) catheters. Launched four products into the marketplace since joining in April 2011.Skilled in creating project life cycle plans per ISO 13485, risk assessment, packaging, ISO 10993 biocompatibility, sterilization validation, verification & validation testing, process qualification, manufacturing transfer, and clinical readiness. Contributor for FDA 510(k) and EU CE Mark submissions.Plan and conduct animal studies, evaluating device concepts and gathering user feedback. Manage initiation of clinical studies, identifying domestic and foreign study sites and partners, provide information to ethics review boards.Write test methods, protocols, reports, and technical drawings. Create dFMEA and System Hazards Analysis per ISO 14971. Skilled in catheter design, Nitinol processing, silicone overmolding, injection molded part design, adhesives, DFM, soldering, process development, and hands-on laboratory skills. Skilled in design of assembly & test fixtures, and in communication of technical concepts.Creator of novel IP and contributor to patent strategy. Member of due diligence teams to acquire / license competitive and emerging technologies.Innovator of the Year, 2013. Member of Medtronic’s Global Innovation Fellowship group. R&D manager of Medtronic annual intern program since 2012. Selected for the Leadership Development Program. Site lead for Medtronic’s Women in Science & Engineering initiative.

Project and Technical Lead for helical femoral artery stent and delivery system, developing product through three generations. Integrated stent, delivery catheter, and deployment handle. Solely developed deployment-assist handle, integrating spring-force elements to reduce the force a physician applies during deployment. Developed catheter delivery system for stent lengths up to 250mm long. Created loading fixtures, processes, and test methods, and skilled in catheter processing techniques and design. Designed self-expanding Nitinol femoral artery stents, using photoetched sheet and electropolishing techniques. Evaluated stent performance, deployment, and fatigue resistance.Key contributor in chronic and acute animal studies in an ovine model. Created documentation supporting CE Mark clearance, leading to human clinical trials. Successfully filed and received four patent applications.NovoStent Employee of the Year, 2007.

Performed several tasks dedicated to researching and improving self-expanding neurovascular stents and platinum-coil based aneurysm treatments. Responsibilities included designing product variations for evaluation, testing prototype products, and writing standard test methods and protocols.Determined physical properties of new material samples using SEM and FTIR, and analyzed the feasibility of implementing material from new suppliers into current production methods. Assisted with the design, creation, and presentation of neurovascular models to present and test medical device products.