GABRIELA GAMORY
Oakland
Summary
R&D Engineer with experience in medical device development, usability testing, and user-centered design. Skilled in translating clinical and technical requirements into actionable design solutions, leading studies and physician panels, and supporting IDE submissions and device launches. Proven cross-functional collaborator and technical leader with a focus on human factors and user experience.
Overview
4
4
years of professional experience
Work History
R&D Engineer II
Medtronic Structural Heart | Mitral & Tricuspid Therapy Delivery Group
07.2023 - Current
- Ensured traceability of design inputs through verification/validation activities, strengthening audit readiness and regulatory compliance.
- Developed a pulsatile heart model to support design validation efforts and enable physiologically relevant testing conditions.
- Led a physician panel to gather Voice of Customer (VOC), directly informing design development and usability considerations.
- Served as subject matter expert in echocardiography, quantifying variability in imaging to support Deployment Accuracy initiatives across Mitral & Tricuspid programs.
- Successfully transferred test methods across sites, demonstrating strong cross-functional collaboration and technical expertise.
- Recognized as a “Pioneer for Inclusivity” for advancing diversity initiatives and fostering cross-functional collaboration.
R&D Engineer I
Medtronic Structural Heart | Mitral & Tricuspid Therapy Delivery Group
06.2021 - 07.2023
- Contributed across Phases 1–4 of product development for a novel Transcatheter Mitral Valve Replacement (TMVR), from early concept generation and feasibility testing through verification, validation, and regulatory submission.
- Compiled engineering deliverables, technical reports, and risk analyses that directly supported successful IDE submission for the delivery system, enabling FDA approval to initiate clinical studies.
- Spearheaded pre-clinical efforts within tiger team, developing procedural content and medical education materials prior to clinical study launch.
- Owned and delivered Protocol Deviation Reports (PDRs) and multiple Root Cause Investigations (RCIs) to support timely issue resolution and successful IDE submission.
- Acted as subject matter expert for design visual and dimensional testing, ensuring objective, repeatable, and reproducible evaluation criteria.
- Recognized for fostering collaboration, driving engagement, and energizing teams with a positive, proactive approach.
Education
Bachelor of Science - Biomedical Engineering, Minor in Mathematics
University of Hartford
West Hartford, CT05.2021
Timeline
R&D Engineer II
Medtronic Structural Heart | Mitral & Tricuspid Therapy Delivery Group
07.2023 - Current
R&D Engineer I
Medtronic Structural Heart | Mitral & Tricuspid Therapy Delivery Group
06.2021 - 07.2023
Bachelor of Science - Biomedical Engineering, Minor in Mathematics
University of Hartford
SKILLS
Design verification | Design validation | Pre-Clinical testing | Usability testing | Procedural development | Design of Experiment (DOE) | Predictive modeling | Root Cause Analysis (RCA) | Measurement Systems Analysis (MSA) | Requirements gathering | Specification development