Responsible for development and/or improvement of Quality Management System processes related to ISO 13485 and ISO 9001.Provide oversight of Medical Device Engineering Design and Validation, Cleanroom Manufacturing and Quality Control activities. Supplier audits of medical device components suppliers and service providers. Supervisor of Quality Technician and Document Control personnel.

Perform failure investigation of medical devices being returned from clinical trails. Determine root cause failure mode and document findings. Propose product design changes in order to eliminate common failure modes.

Responsible for improving the manufacturing process and tooling used to injection mold high voltage power connectors utilized by electric power companies.Extensive use of the Toyota A3 template to identify and eliminate high volume or dollar scrap issues. Use of Creo/Pro-E 3D CAD and GibbsCAM machine programming in support of tooling need.Machine Shop Supervisor

Perform EMI/EMC compliance testing, at the Honeywell Deer Valley facility, on R&D prototype avionics packages.

•Worked as part of the core team to implement ISO9001/AS9100 Quality Management System, along with lean manufacturing.•Collect and analyze non-conformance data, perform Failure Analysis of production and customer returns to determine Root Cause Corrective Actions. •Conduct Design of Experiments to evaluate new materials and build methods. Redesigned manufacturing solder/build fixtures to eliminate mechanically induced failures.•Participate in Engineering Design Reviews to ensure compliance with customer specification requirements, provide analysis of suitability of the proposed design against known end user environmental conditions.•Test Engineer - Interpret customer performance requirements; create Qualification Test Plans outlining test methods and requirements for aerospace and defense hardware; and the completed Qualification Test Reports. Create standardized production test procedures in accordance with various military and civilian test specifications. Introduced automated test systems and designed test set-ups and fixtures. Responsible for overseeing component; in-process/final assembly electrical and environmental testing; along with customer qualification testing.