Stephen Roller Email & Phone Number

Managing early stage for cardiac catheter based technology projects to meet clients needs for development and funding.

Baltimore, Maryland Area

Advising the UM ventures group inside the university on startup medical device companies formed from university IP. Projects range from market potential and evlaution of an idea, strategy to prototype and test, R&D and regulatory strategy for development, and relationship management with strategic partners.

Washington D.C. Metro Area

Providing strategy consulting, market intelligence, and customer insights to medical device startups and entrepreneurs evaluating new opportunities.

Mounds View, Mn

Led R&D effort for the creation of the next generation transcatheter heart valve from concept to FDA approval. Facitlitated concept ideation, feasibility testing, IP generation, and review of the IP landscape for the device. Funneled these activities into down selecting a concept and obtained cross-functional support to initiate bringing the product to market. Formed a team and establishing resources to finish product R&D work and manufacture the product. Delivered the necessary testing and data to support regulatory submissions and provided field support to the clinical trial that resulted in regulatory approval for the product.

Mounds View, Mn

Headed cross functional team to successful launch of class III implantable device. This included scoping the project with multiple stakeholders, negotiating for resources and then ensuring that their stakeholder requirements were met. Managed budget, timeline, project risks, and product quality. Facilitated launch planning process with marketing and operations to exceed launch expectations.

Mounds View Mn

Led an engineering team to meet all product requirements for the development of two next generation products. Responsibilities included planning device needs along with test strategy and logistics, collaborating with manufacturing to ensure manufacturability of the design, initiating control charts for tracking device performance, and conducting technical reviews.Supported the marketing and sales organizations through analysis of VOC tradeoffs, product education presentations to customers in small group and large conference formats, and refinement of product launch materials.

Brooklyn Center, Mn

Specialized in the implementation of manufacturing automation and equipment for battery production. This included vendor selection and project management of budget and timeline for local as well as international development partners.

Master'S Degree, Biomedical Engineering

Activities and Societies: Conducted research at the Orthopedics Research Lab

Master Of Business Administration (M.B.A.)

Specialization - MILI (Medical Industry Leadership Institute)

Bachelor'S Degree, Mechanical Engineering

Activities and Societies: Pi Tau Sigma (Mechanical Engineering Honor Society), ASME