Assembled and supervised a software test team to develop software system and software integration tests for a single-port surgical robot. Helped to develop processes and procedures for medical device software development on the De Novo path and the Software Development Lifecycle (SDLC) using IEC 62304. Further developed technical expertise in Automated Testing, Microcontrollers, and electromechanical design. Provided inter-departmental support and software department lead in robotics and microcontrollers including kinematics, control theory, and motor control/mechanics. Developed and provided leadership for the software test team including managing the recruitingprocess, project management, resource planning, mentoring, and technical guidance. Expert in SDLC processes and process improvement with an emphasis on software verification. Guided company, software team, and software test engineers as the medical device software test engineering expert.

Hired to drive the verification and validation of a novel intravascular ventricular assist device currently in clinical trials for providing cardiac support to bridge-to-transplant patients. Authored and demonstrated the successful practice of FDA compliant standard operating procedures (SOP) and templates for the verification and validation process, tool validation process, and deviation process which led to increased efficiency in the testing lifecycle. Managed and mentored mid-level and junior-level engineers in the test lifecycle. Led and completed system testing efforts for four medical device application software updates.  Quick Turnarounds: Generated and executed system testing for software patches thereby eliminating bugs and improving features in a short timeline. Improved Test Process: Developed and released standard operating procedures (SOP) for the verification and validation process for manual and automated testing within FDA regulations including handling of deviations and tool validation. Continuous Improvement: Learned automated testing capabilities of MATLAB and Simulink in parallel with software development transfer to MATLAB and Simulink in order to reduce software lifecycle timelines. Team and Contractor Management: Excelled as the Software Test Lead for the NDU 2.0 project (long term > 1 year) incorporating the unit testing, integration testing, and system testing of the NDU 2.0 software, PulsePro Software, and LCD Software.  Project Management: Created comprehensive and realistic testing timelines to keep open communication with management. Resource Management: Enhanced, validated, and maintained custom equipment utilized for system testing. Product Investigations: Processed and investigated failures of the incoming returned components of the iVAS system and completed unscripted testing on developing software.

The Women’s Health and Cancer Sustaining Engineering group maintained the existing line of BD Totalys™ sample preparation and BD FocalPoint™ cancer screening diagnostic devices. Recruited to master the suite of robotic diagnostic systems to improve the quality of the devices through system verification and validation. Led and conducted multiple system verification and validation activities across multiple platforms. Molded newly hired international test engineers and test leads to ready them for success within their positions.  Independent: Performed as the sole test lead and test engineer for an internationally driven product. o Devised the planning and implementation of system testing and software testing for the BD Totalys™ D-CUBE, a BD Japan high priority project to bring automated sample preparation to small-scale laboratories using MS Office, Waterfall development process, MS Project, TFS, and MS Visual Studio. Multidisciplinary and Team Oriented: Excelled as a test engineer in multidisciplinary teams to drive product updates to market in a timely manner. o Wrote, perfected, and executed system testing and software testing protocols using MS Office, TFS, MS Visual Studio, and the Waterfall development process to improve functionality on the BD Totalys™ SlidePrep, BD FocalPoint™ GS Review Station, and BD FocalPoint™ Slide Profiler Workstation (Test Lead) while coordinating with cross functional teams including representatives from management, engineering, medical affairs, manufacturing, regulator, and quality. Presented with the Big Hit award for significant contributions to the business for the work on BD FocalPoint™ GS Review Station. Agility: Quickly obtained proficiency with new equipment to support the maintenance needs of the Assay Development group.

Bioptigen (acquired by Leica Microsystems) is a medical device company, a technology leader on Optical Coherence Tomography (OCT) medical market, specializing in bringing novel imaging solutions to the ophthalmic research and clinical communities.As a Product Specialist, I continued with my responsibilities from my previous position with Bioptigen, Inc. In addition to those responsibilities I designed verification and validation plans and protocols, conducted testing and troubleshooting for products making improvements based upon findings, and authored reports for multiple software products and software/hardware manufacturing equipment for new FDA approved EnFocus and EnVisu systems. I coordinated with software R&D, customer service, and product management to maintain and update the software change request backlog. I managed a software verification and validation team to test the primary software product (InVivoVue acquisition software). I learned and utilized the Company's visual time management strategies to maintain, evaluate, and display time management of multiple running projects. Average of 2-3 projects at once.

Bioptigen (acquired by Leica Microsystems) is a medical device company, a technology leader on Optical Coherence Tomography (OCT) medical market, specializing in bringing novel imaging solutions to the ophthalmic research and clinical communities.As an SQA/Project/Support Engineer, I created and executed verification and validation testing for software and hardware products. Wrote reports to support investigations, necessary design changes, and process improvements. Created/revised processes for quality control and manufacturing work instructions and assisted with design transfer of multiple products (software, hardware, and/or electro-mechanical) from engineering to manufacturing. Functioned under the document control system to author new documentation, modify existing documentation, and phase out obsolescent documents. Created and edited technical requirements for multiple software and hardware products. Created and edited design specification for multiple software and hardware products.

Bioptigen (acquired by Leica Microsystems) is a medical device company, a technology leader on Optical Coherence Tomography (OCT) medical market, specializing in bringing novel imaging solutions to the ophthalmic research and clinical communities.As a Biomedical Engineering Intern/Commercial Support Engineer, I performed testing and analysis of automated segmentation software and compared it to the manual segmentation "gold standard".

SMAT - Special Unit, Disaster Relief Strike Team, responsible for patient care and logistics for shelters and other emergent needs in the field. Deployed during Hurricane Irene to Greenvile/Grifton, NC.

EMT - Intermediate, Part-time position, 1-2 12 hour shifts per week, 3rd person. Responsible for patient care and transport of patients to various medical facilities in the Durham County 911 system.

BME 204 - Biomedical Measurements TA. This course will introduce students to modern topics in biomedical engineering and areas of emphasis in the biomedical engineering curriculum through the study and use of biomedical measurement tools. The course will include a lecture and a laboratory component.I was responsible for reinforcing lessons presented by the professor by reviewing materials and guiding laboratory sessions/experiments for 20 BME students. I enforced school and class rules to help teach students proper behavior and expectations in a laboratory environment. Assisted the professor with tracking attendance, recording resources used, and calculating grades.

Milled and fabricated metallic and polymer components for various products.

The research focus of the Michael W. Krzyzewski Human Performance Lab (K-Lab) is the preservation of long-term joint health through injury prevention and rehabilitation following injury. In order to accomplish these goals, the K-Lab brings together a multidisciplinary team of orthopaedic surgeons, biomedical engineers, kinesiologists, physical therapists, and athletic trainers.I was responsible for gathering balance board data from Total Hip, Knee, and Ankle replacement pre-op and post-op patients. I assisted in the compilation and statistical analysis of the data. Additionally I assisted in the acquisition and analysis of data from 3D gait technology.