FDA-approved organ preservation system replacing cold-storage transplant standards
TransMedics manufactures the Organ Care System (OCS), a medical device that preserves donor organs outside the body—replacing static cold storage, the decades-old transplant standard. The company is scaling manufacturing (NPI projects for perfusion sets) while expanding internationally (Italy launch underway) and upgrading core ERP systems from QAD to Oracle Fusion and SAP, signaling operational complexity growth. Hiring velocity is accelerating across healthcare, manufacturing, and engineering, with active pain points around donor organ utilization, FAA logistics compliance, and quality-management system maturity.
Notable leadership hires: Regulatory Affairs Director
TransMedics is a publicly traded medical-device company founded in 1998 and headquartered in Andover, Massachusetts. The company develops organ-preservation technology for transplant centers, enabling assessment and optimization of donor organs before transplant surgery. The OCS platform holds FDA approval for lung, heart, and liver transplant indications in the U.S. and operates a nationwide logistics network (National OCS Program) combining clinical expertise, 24/7 support, and dedicated air and ground transport. The organization is commercial-stage and partnerships with transplant stakeholders across the U.S. and internationally, with active expansion into the Italian market.
The Organ Care System (OCS), an FDA-approved device for preserving and assessing donor organs (lung, heart, liver) outside the body. It replaces static cold storage and includes a nationwide logistics network and 24/7 clinical support.
Embedded systems (C, C++, ARM, PIC, QNX), CAD/design (SolidWorks), control systems (PLCs, JTAG), manufacturing execution (MES, QAD), and enterprise planning (Oracle, SAP). The stack reflects medical-device firmware and regulated manufacturing operations.
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