Taking novel technology from lab to released medical device.

Worked at AstraZeneca. Ran worldwide device project across many clinical trials and commercial arenas. Managed changes to device over lifecycle. Coordinated with global clinical trials. Launched product for a number of new indications. Managed changes and updates to design controls, and managed testing protocol and reporting. Worked as project manager for global fill finish lines. Worked on design history file optimization for prefilled syringe and autoinjector lines. Developed internal assembly line for prefilled syringe rapid DV testing.

Wrote protocols for Verification tests. Worked with test lab to ensure testing completed. Troubleshot delays in testing process. Wrote reports on completed tests, and communicated with team any failures and trends in test data. Assisted in design improvements and strategized design changes with worldwide supply chain.

Created verification & validation protocols and reports for design elements of hydrogel electrodes to for defibrillation devices. Worked creating protocols, generating reports, and performed various test methods when needed. Worked closely with internal and external test labs. Extensive work with Agile and Solidworks

Worked on Sustaining Engineering team on post market spine products. Provided R&D input on manufacturing change orders. Ensured all changes were concurrent with procedures and design controls, and identified and filled gaps where needed. Worked extensively with Windchill and ProE CAD for change control process and drawing updates. Worked closely with cross functional group and manufacturing sites to ensure changes were completed.

Built a surgical tool tracking platform from scratch. Integrating machine vision and sensors into an area previously ignored by other developers through an extensive contextual design process. Our system captures what is used during surgery from boxes already present in every surgery, and then can give you data on what is used in order to achieve a much more efficient surgical process.

As a contractor I worked on graphic cases, small toolboxes for surgery. Tasks included tolerance stacks to ensure proper fits, biological safety evaluations of materials used in and on the graphic cases, design of mechanical test studies for verification and validation, and work in ProE/Creo CAD software to update models and drawings of products as well as creating new test fixtures from scratch.Also updated risk analysis (DCRM, FMEA, DHF) remediation on legacy surgical implants for craniomaxillofacial (CMF) products to update them to modern FDA standards. Coordinated between Development Engineers and a team in India to update occurrence for failure rates, and use that information to update the risk documentation.

Organize and investigate complaints on knee implants and instruments. Responsible for Corrective and Preventative Actions (CAPA) process on trending complaints. CAPA resolution entailed adjusting Design History Files, product training, and geometric tolerating and dimensions. Analysis for investigations involved Scanning Electron Microscopy, Finite Element Analysis, and strength and tensile testing. Worked and coordinated with New Product Development, Quality, Regulatory, and Product Surveillance teams to implement changes.

Ran an ethnography study using Contextual Design to design a solution for Air Force pathologyimplement Digital Scanning processes in the Pathology department’s workflow.Evaluated all available products on the market that fit the Air Force needs. Brought together severalmillion dollar medical product companies to share data and system information in a structuredformat in order to determine what product and service would best fit the Air Force.The initial design work we performed lead to eventual expansion of the project from 4 sites, toDepartment of Defense wide implementation

Wrote MatLab code to compare any EMG data quickly to data recorded from neural electrodes, andassisted in designing and building a mount for a robotic arm to present targets during experiment. Thesimple mount I designed in SolidWorks is still in use today for human trials, and can be seen in thisvideo.http://www.youtube.com/watch?v=yff20TlHv34