Director Of Product Development
CurrentResponsible for interfacing with clients to derive and formalize user needs and requirements and manage the technical aspects and risks of their product development. This includes timeline and design planning, risk planning and analysis, and verification and validation planning and execution in pursuit of regulatory approval. Participate in the development of client designs including mechanical and electronic CAD, microcontroller firmware, PC user interface software, and component selection and sourcing. Create company processes and protocols and manage technical capabilities to fit client project needs.Created and currently maintain in2ctrl - an internal, web-based application for the control of client documents and records.Created and currently maintain PathSurveyor (https://pathsurveyor.com) - a web-based tool for determining FDA medical device classification and identification of predicate devices.