As a Mechanical Engineer of the Sustaining Engineering team, I supported TransMedic's Organ Care System, a revolutionary technology for preserving organs used in the treatment of end-stage heart, lung, and liver failure and the only FDA-approved technology for organ transplantation in the U.S.

In my time at TransMedics, I led multiple business sustaining projects, independently managing 2-3 initiatives at a time while overseeing project schedules and delivering regular updates to senior management. I led key stakeholder meetings to translate customer requirements into system specifications, ensuring alignment with business goals. I developed and executed verification and validation (V&V) protocols based on these requirements, maintaining product performance and regulatory compliance. I collaborated with various functional departments, including field service, manufacturing, clinical, and supply chain, to provide ongoing product support and drive cross-functional improvements. I also spearheaded the testing and validation of an alternate blood heater, coordinating efforts with external labs and international manufacturers. Additionally, I initiated and led the redesign of the OCS Heart organ chamber support structure, optimizing it for manufacturability and incorporating usability feedback from clinical teams, with plans for trial in the research lab.

Responsibilities: V&V Testing, Technical Reports & Analysis (Excel & Minitab), Detailed Drawings & Release, Engineering Change Orders & Design Control, Design Reviews, Stakeholder Management, Project Management, Manufacturing Process Development, IQ/PQ/OQ & Process Validation, Cross-Functional Working Relationships (Sustaining, Manufacturing, Engineering, Regulatory, Quality Assurance, Supply Chain), QSR, GMP, Statistical Sampling, Root Cause Analysis, Vendor Relationships, Mentorship