Principle Quality Engineer

• Jul 2023 - Present

Senior Quality Engineer

• Mar 2020 - Jun 2023

Quality Engineer

• Aug 2017 - Mar 2020

Quality Engineer II

• Feb 2014 - Jul 2017

At CardioMEMS/St. Jude Medical (now Abbott) I supported manufacturing ramp up following FDA PMA approval of a class III implantable MEMS sensor. Lead the investigation, resolution, and prevention of product and process nonconformances. Responsible for maintaining failure mode effects analysis (FMEA). Responsible for the ethylene oxide sterilization parametric review and release of product, reviewing bioburden results, and bacterial endotoxin testing result. Provide quality review and approval of process specifications, material specifications, validation protocols and reports. Provided device manufacturing expertise to complaint investigation. Trained, mentored, and managed quality technicians and inspectors. Show less

Product Development Engineer II

• Mar 2013 - Feb 2014

Design and develop devices for spinal fixation including gathering clinical input, concept development, prototyping, and completing a design history file. Generate solid models and design drawings/specifications of surgical implants and instrumentation as well as implement changes and additions to product lines through a design change process. Responsible for obtaining CE mark for two spinal device product lines. Managed a Notified Body technical file audit and prepared the technical files of those product lines. Primary engineering resource for the FDA submission of both a Special and Traditional 510(k) for a spinal implant system. Managed and serve as primary engineering resource for the approval of four spinal device product lines in China. Show less

Research Program Coordinator for the Atlanta Pediatric Device Consortium

• Mar 2012 - Mar 2013

Managed a multi-million dollar FDA sponsored nonprofit to develop pediatric medical devices and worked with 16 start-up companies to provide resources for technology transfer. Authored quarterly reports, budget reports, and annual reports to the FDA and communicated with the FDA concerning regulatory pathways and guidelines for pediatric device projects. Managed a multi-million dollar FDA sponsored nonprofit to develop pediatric medical devices and worked with 16 start-up companies to provide resources for technology transfer. Authored quarterly reports, budget reports, and annual reports to the FDA and communicated with the FDA concerning regulatory pathways and guidelines for pediatric device projects.

Project Engineer

• Jul 2011 - Jan 2012

Operations Intern

• Oct 2010 - Jul 2011

Worked with Operations Engineers to develop and define documentation and processes used in the production of medical devices.

Undergraduate Assistant

• May 2007 - Dec 2010