TransMedics, Inc. • Andover, MA 05544 • Posted today via LinkedIn
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The Senior Design Quality Engineer at TransMedics, Inc. is responsible for a variety of Design Quality Engineering functions in support of product development, including risk management, design verification, design validation, design assurance activities, manufacturing process development support, and statistical analysis. This role involves ensuring the health of the design control process, partnering with development and engineering departments to meet design control requirements, and acting as a subject matter expert on design control processes and Quality Engineering.
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.
This position is responsible for various Design Quality Engineering functions in support of product development such as risk management, design verification, design validation, design assurance activities, as well as manufacturing process development support, and statistical analysis.
ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:
REQUIREMENTS:
EDUCATION:
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