Senior Electrical Engineer

TransMedics' Sustaining Engineering team is looking for a talented Electrical Engineer to help transform organ transplantation. Reporting to the Sustaining Engineering Manager, the Senior Electrical Engineer will act as the subject matter expert and primary point of contact within the Operations group for all electrical matters. This is a critical role that drives change to on-market products, leads product improvement efforts, and supports manufacturing and NPI in design for manufacturing, assembly and test. ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE: Lead electrical and contribute to cross-functional engineering efforts for a complex, software-controlled electro-mechanical medical device comprised of capital equipment and disposables Own changes to existing PCB, electrical, and electro-mechanical assemblies for on-market products with minimal oversight Responsible for designing and rapid prototyping concepts and iterating through the design process Ensure compliance with Design Control regulations, including, but not limited to, specification development, risk analysis, design reviews and verification and validation protocols and reports Work closely with product development engineering, manufacturing engineering and contract manufacturers to ensure new electrical designs are capable of being assembled and tested using modern manufacturing methods Prepare and execute verification and validation test plans Provide direct support to contract manufacturers for supply of PCB assemblies and PCB-level components Generate and through formal change order processes, maintain schematic, PCB, and PCBA documents Create written specifications, block diagrams, and functional description documents Prepare for and lead electrical design reviews, and contribute to system-level design reviews Address field issues by determining root cause and implementing corrective actions as necessary SKILLS/REQUIREMENTS BSEE with 8 years of experience or MSEE with 6 years of experience performing circuit design and PCB layout for complex electro-mechanical medical devices Circuit design and simulation experience including microprocessor, analog, digital, motion control, power supplies, and battery & power management Knowledge of design for manufacturing & assembly and design for test principles Experience with battery design and testing preferred OrCAD Capture & Allegro PCB Designer experience is strongly preferred Experience with LabVIEW, Assembly, C/C++ programming a plus Successful track record of working in fast-paced and dynamic organizations Demonstrated record of curiosity, innovation, and creative problem-solving with an entrepreneurial spirit Must be reliable, a self-starter, and able to work independently, as well as work collaboratively Strong written and verbal communication skills Understanding of medical device development processes including experience with FDA CFR 820, IPC Standards, IEC standards and ISO 13485 regulations Skilled at reworking PCB assemblies while performing soldering/de-soldering of fine pitch PCB components TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees. Welcome to TransMedics Careers! Our Vision is to help save more patients' lives by becoming the trusted partner to transplant stakeholders worldwide and delivering the highest quality technology, service and clinical care. TransMedics Group, Inc. (TMDX) is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We developed the Organ Care System, or the OCS, to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. Our innovative OCS technology replicates many aspects of the organ's natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. In concert with our OCS technology platform and OCS Connect app, which enables TransMedics and transplant clinicians to efficiently track, coordinate & communicate resource logistics for donor organs procured and maintained on OCS, TMDX launched its National OCS Program (NOP) in 2022: 16 regional hubs across the U.S. staffed by a dispersed workforce of experienced, on-staff OCS Perfusion Specialists & Cardiothoracic and Abdominal Donor Procurement Surgeons. These resources are mobilized on-demand via our own dedicated ground & aviation transportation logistics network, to retrieve and deliver allocated donor organs from anywhere in the U.S. - aiding U.S. Transplant Centers in bidding farewell to the time & distance limitations of cold storage & expand the pool of viable donor organs for their transplant recipients.