Managed product development from concept to end of life, including but not limited to cannula insertion systems, vitrectomy probes, pneumatic drivers, and the development of proprietary test equipment.· Responsible for analysis of project scope and customer feature request.· Responsible for the creation of project plans that met stakeholder and customer needs or requirements.· Responsible for the allocation of resources and roles to ensure that all facets of the project are meeting expectations.· Managed communication across departments to schedule and plan relevant meetings, deadlines, and forecasts.· Communicated progress and roadblocks to stakeholders, including executive management, and made recommendations to remove roadblocks leading to on-time and on budget deliverables.· Created high level report and documentation, including but not limited to, risk analysis, customer requirements specifications, product requirements specifications, traceability matrices, and project overview.· Performed process capability analysis of various manufacturing activities in order to determine whether processes were meeting required specifications. Modified and/or improved various manufacturing processes as required to increase overall throughput, including but not limited to the decrease in scrap rates of certain processes by up to 45%· Assisted in vendor auditing for qualification and conformance.

Managed projects that qualified, verified, and validated processes or equipment used to develop and manufacture pharmaceutical products such as the implementation of sterile barrier sealing, cleaning, and adhesive bond curing.· Managed all facility maintenance and validation systems.· Developed validation protocols and standard operating procedures based on internal and external regulations and/or requirements to decrease the risk of encountering non-conformities found in manufacturing.· Performed device characterization of next generation prototype medical devices which laid the foundation for various successful product launches.· Established, by objective evidence, that all key aspects of process equipment and ancillary system installation adheres to the manufacturer approved specifications.· Established, by objective evidence, that all processes, under anticipated conditions, consistently produce a product which meets all predetermined requirements.· Established, by objective evidence, process control limits and action levels which result in a product that meets all predetermined requirements.· Prepared reports and/or data (Installation Qualifications, Process Qualifications, Operation Qualifications, Equipment Maintenance Processes, Software Specifications, etc.) prior to release of equipment or processes for production use.· Performed detailed analysis of non-conforming materials or processes and used the findings to drive Corrective and Preventative Action (CAPA) improvements.· Worked with cross functional and external teams to identify the root cause of failures through the NCR and NCMR processes.· Performed all troubleshooting of technical issues, verification, and calibration of equipment used for testing scenarios.· Developed preventative maintenance and calibration system improvements that successfully reduced the number of out of tolerance findings by approximately 90%.

Part of a User Acceptance Team that assisted in the testing of new products for various clients.· Openly worked with and communicated with various moderators and test locations to collaborate on the completion of test case scenarios.· Required to write bug reports via bug tracking system.· Performed various levels of usability and functionality testing of client products.· Responsible for the organization and preparation of projects which involved setting up and troubleshooting equipment.

Managed and/or worked on teams that performed various stages of web, hardware, and software development testing for Microsoft products such as the Surface, Xbox One, HoloLens, and the related accessories.· Supervised test facilities, including scheduling tests, sourcing procedures, and acted as a primary contact for clientele. · Responsible for the organization and preparation of projects which involved setting up and troubleshooting equipment.· Performed both automated and manual diagnostics tests for integration, interoperability, bug regression, usability, install/uninstall, early warning protocols, sanity, and functionality of various product lines.· Created process documentation for quality assurance and automation test scenarios.· Compiled and investigated datasets before submission to the client.· Executed test cases involving the communication behavior of machine-to-machine communication devices via Bluetooth technology.· Designed and conducted thermal testing on hardware via test scripts that worked hand-in-hand with additional proprietary testing applications.· Executed power consumption testing on hardware via diagnostic tools and proprietary testing applications.· Wrote and reported bugs directly to the client in person and/or by the Team Foundation Server bug tracking system.Openly worked with and communicated with offshore facilities to collaborate on the completion of test case scenarios.