Gary A.

About Gary A.

Engineering manager with a variety of experience in the design and development of medical devices and systems including class 3 implantable devices, CT and MRI imaging systems and patient monitoring systems. Experience in leading large and sometimes geographically distributed software teams on complex projects. Extensive experience in ISO 13485, ISO 14971, IEC 62304, and various 60601-x, 60602-x standards.Broad knowledge of hardware/software systems including a variety of platforms, operating systems, languages, and computer technologies. Strong background in embedded real time development as well as Windows.NET desktop/web development.Specialties:Management of R&D engineering teamsMedical device product development and managementFDA and European regulatory standards for medical devicesClass 3 implantable medical devices and related standards ECG telemetry monitoring systems and diagnostic systems Medical imaging systems including CT and MRIPatient monitoring devices and systems

Experience

1. Software Manager

   Scottcare

   Dec 2014 — Present · Cleveland/Akron, OH, US

   Assemble and manage a team of software engineers for the development of a next generation cardiac and pulmonary rehabilitation system leveraging next generation ECG telemetry devices. Work with product and sales managers to assess business requirements. Build and train team of software engineers. Lead software architecture effort and assist directly with software design and development activities. Perform usability studies at customer sites and improve UI and workflows based on feedback. Perform cross functional project management coordinating with regulatory, quality, service and manufacturing engineers to assure successful product launch.

Education

• The University of Akron

  30+ graduate hours, Biomedical Engineering and Electrical Engineering

  1987 — 1989

• The Ohio State University

  BS, Electrical Engineering

  1979 — 1984