Vp Operations
Invisionheart (A Vanderbilt Startup And 2013 Jumpstart Foundry Cohort)
Greater Nashville Area, Tn
Program Mgr – Oversee solution architecture and program teams in US, India & Taiwan− HW Dev: Coordinates requirement specifications, manufacturing and validation− SW Dev: Manage Dev teams (FW, Mobile iOS Application, Cloud, Web Client)Product Owner – Actively directs product backlog− Author of over five hundred User Stories for FW, Mobile App, Cloud and Web Client− Produced over four hundred requirements for HW and SW specifications Scrum Master – Facilitates Agile development activities for teams in US & India− Pioneered the introduction and adaptation of Agile scrum for all development teams− Designed and built Jira workflow, project, boards and reporting solutions− Facilitates Sprint planning, standup, close and retrospective meetings− Coordinates continuous integration & deployment of FW, Mobile App, Cloud & Web Client SWValidation Mgr – Authors validation test plans/results and manages teams in US, India & Taiwan− Designed and built Jira workflow for validation test plan, test assignment and reporting solutions− Produce and Approve over one thousand test plansRegulatory Affairs – Delivered two FDA 510(k) applications on time and on budget− Manages the regulatory affairs for the business with two industry consultants including strategy− Contracted and managed certification labs to complete all required compliance testing− Actively participates in the development of the appRisk Management Analysis, Usability Analysis, Operators Manual, and Traceability ReportsManufacturing – Develops and implements FDA Quality Management System (QMS)− Built out the manufacturing space with capacity to produce over two hundred units per month− Manage incoming inspection of all hardware components− Manage assembly inspection and delivery of the hardware assembliesQuality Assurance – Pioneer FDA & EU compliant workflows and processes for all SW/HW− Defined FDA compliant quality processes for the business− Primary Quality Contact for the business