Senior Design Quality Engineer

TransMedics, Inc., headquartered in Andover, MA, is revolutionizing organ care.  With the goal of bringing new life to organ transplant, the pioneering Organ Care System (OCS™) was developed to address the major limitations of the current standard of care, cold storage.  The OCS System serves as a portable, miniature intensive care unit that helps preserve donor organs in a near-physiologic state during transport.  Unlike traditional cold-storage methods, the OCS System features ex-vivo, warm perfusion, and provides the means to monitor organ health, so that transplant patients can experience better outcomes. The only multi-organ platform, with the largest body of clinical evidence, the OCS System is designed to increase utilization and transplant volumes so that more transplantable organs can be made available worldwide.  The Organ Care System is nothing less than a paradigm shift that can help transform organ preservation and optimization so that more patients can benefit from life-saving transplant procedures.

The Senior Design Quality Engineer to join our team in Andover, MA.  The Senior Design Quality Engineer role plays a critical role in ensuring medical devices meet safety, effectiveness, regulatory compliance, and business requirements throughout the design and development process.  Reporting into the Quality Department, the Senior Design Quality Engineer will collaborate with cross-functional teams supporting New Product Development and Sustaining Engineering projects for complex electromechanical medical devices, with a key focus on Software (embedded and standalone).  The Senior Design Quality Engineer will provide input to the project teams for project decisions and development activities, ensuring the execution of design control and risk management activities in accordance with internal procedures and applicable standards/regulations.