Robert Mackinnon Email & Phone Number

Murrieta, California, United States

Start up of manufacturing for Rev1 Engineering. Opening of modular Class 8 cleanroom meeting all FDA governed certification requirements. Staffed manufacturing personnel. Identified and assisted in the delivery of an electronic Quality Management System (Green Light Guru).Prior to opening manufacturing site, served as a Program Manager for Rev1 Engineering. Worked with 5 separate clients (Class1 - Class3 devices) to deliver an array of medical devices. Responsible for budgeting, staffing, communication to client. Utilized Pro Chain program management system to dictate and communicate all resource requirements while maintaining project status.

Temecula, California, United States

Start up company introducing a nephroureteral catheter. Opened manufacturing site in Temecula, CA. Starting at ground zero, completed staffing of site, implemented paper based Quality Management System. Responsible for the installation and qualification of a Class 8 cleanroom. Delivered product through FDA requirements to achieve a 510k acceptance. Identified and purchased equipment and developed processes to meet sales/marketing demands. Set up Incoming Quality area (staffing and equipment) and defined criteria to accept materials to build product.Post planned acquisition by Merit Medical, led the transfer of the product line to manufacturing site in Pearland, TX.

Temecula, California, United States

Started as a manufacturing engineer, transitioned to R&D and developed and delivered the Flexi-Cut Atherectomy Catheter (including patent). Advanced to an Engineering manager overseeing manufacturing, product development and the CAPA department. Hired numerous engineers and technicians and oversaw a department with 60 technical staff members.

Master'S Degree, Arts And Management

Bachelor'S Degree, Mechanical Engineering - Manufacturing