Led design verification and validation (V&V) strategy to produce compliant regulatory submissions within Class III HVAD System:• Responsible for audit readiness by reviewing regulatory submissions within my area of expertise and answering submission responses. Projects were submitted to FDA, BSI, and PMDA with zero findings within V&V.• Generated requirement flow to design outputs and assessed use conditions to determine DV methods for applicable DIRs, due to a DHF remediation commitment to FDA. Contributed to design FMEAs and generated risk-based sampling plans and testing strategies.• Developed and implemented V&V strategy on design change to increase patient population covered to 95% while improving thrombus and blood stagnation. Delivered V&V plans and reports, updates for ISO 10993-1 and -4 compliance, and coordinated builds of production equivalent samples. Submission was Approved in EU and received Approvable from FDA.• Enhanced design control compliance on two major design change projects by creating matrix tracing stakeholder needs, DIRs, V&V evidence, and linking requirements to specific failure modes within design FMEAs to develop risk-based sampling plans.Developed and validated new test methods for V&V testing across multiple programs, as well as provided data analysis and technical reports:• Led execution of IQ/OQ and developed drawings of two Particle Image Velocimetry (PIV) systems: the FDA standard Nozzle to validate CFD, and a pumping ventricle PIV model. Created MATLAB script to assess ventricle stagnation index, performed TMV demonstrating repeatability of the system, and presented results to management at a Technical Review.• Developed and in process of validating bench test method to assess shear strength of the driveline velour. This method will be used in a DOE to show evidence of non-inferiority in a reduced velour length configuration, as requested by Voice of Customer.

Developed design verification and validation (V&V) protocols and reports to support compliant regulatory submissions within Class III HVAD System:• Utilized Design for Reliability and Manufacturing (DRM) tools within a new product development project to address Voice of Customer regarding ease of explant procedure. Created new requirements, improved requirement flow, characterized use conditions, and planned significant cadaveric and in-vivo studies for design characterization.• Responsible for DHF remediation to comply with updated design controls. Work led to a successful Design Closure Design Review and subsequent FDA approval and EU launch of new surgical tools and implantable accessories to address root cause identified as part of a CAPA.• Contributed to FDA approval for Destination Therapy by updating trace matrices linking DIRs to stakeholder needs as well as executing design validation for reliability DIRs, supporting expansion to 2-year useful life for the device.Developed and validated new test methods for V&V testing across multiple programs, as well as provided data analysis and technical reports:• Created and validated a new bench test method to challenge a driveline tunneling use condition.• Planned and executed a cadaveric study to demonstrate clinical relevance of the new test method and validity of a proposed requirement. Work on this project led to DRM Green Belt Certification.• Planned and oversaw data collection for a chronic in-vivo sheep DOE study to characterize a tissue in-growth use condition.• Developed and validated test method to measure blood leak rate of a critical interface between the pump and outflow graft. • Supported development for new pump by creating and validating test method for meeting connector force requirements with respect to intentional and unintentional disconnection as well as connection.• Designed test fixtures using SolidWorks and performed IQ/OQ to support testing efforts across a range of R&D programs.

Worked within mechanical Research and Development to develop Class III aortic stent grafts to treat thoracic aortic aneurysms:• Designed different stents in a wide range of sizes using SolidWorks and developed DHF documentation for multiple projects across the product development cycle.• Performed rapid prototyping and characterization testing to evaluate effect on overall design performance.• Reviewed medical literature, expanding anatomical database for DIR creation and concept development for a new device.• Executed process validation and component qualification activities, as well as tool design and IQ/OQ.

Worked within mechanical Research and Development to develop Class III aortic stent grafts to treat thoracic aortic aneurysms:• Designed different stents in a wide range of sizes using SolidWorks and developed DHF documentation for multiple projects across the product development cycle.• Performed rapid prototyping and characterization testing to evaluate effect on overall design performance.• Reviewed medical literature, expanding anatomical database for DIR creation and concept development for a new device.• Executed process validation and component qualification activities, as well as tool design and IQ/OQ.

Proctor practice SAT exams and evaluate student progress through the course, while also assisting with clerical and administrative duties within the company.

Lead instruction of groups of over fifty students in final exam review sessions as well as training new peer tutors in various subject areas within engineering and the sciences. Tutor physics, mathematics, and circuit theory.

Tutored in many subjects including programming, physics, mathematics, and circuit theory. Also instructed students on more effective studying and test preparation habits.

Modeled primate cranium using 3D software and 3D printing. Gained experience with Brain Machine Interfaces and the fundamentals of Neural Engineering.

Collaborated with production technicians and engineers in the manufacturing of medical devices (hearing aids), while learning about quality control within the medical device manufacturing process.

Assisted in day to day operations within business department of Brazilian headquarters in São Paulo, while learning about the marketing of medical devices (specifically, hearing aids) within a new, emerging market.