Principal Software Test Engineer (Embedded), Lead

Job Description: Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships POSITION SUMMARY We are currently seeking a talented and driven Principal Software Test Engineer (Embedded), Lead to join our team. The Principal Software Test Engineer will have the opportunity to contribute to the life cycle of embedded software applications that preserve donated hearts, lungs, livers, and other organs on the OCS. RESPONSIBILITIES This position is responsible for, but not limited to, the following: Lead the development and execution of manual and automated software test activities Define test strategy, test plans, and test protocols for medical device embedded software, ensuring compliance with regulatory requirements Collaborate with embedded software, hardware, and systems engineers to identify testing requirements and troubleshooting issues. Manage requirements and ensure traceability to all protocols and specifications Design and validate new test methods, software test tools and test fixtures Release all test protocol and fixture documentation using change order process Execute Software V&V test protocols and write verification and validation reports Assist in software test validation, FMEAs, and Design Reviews Maintain test equipment to ensure calibration and preventative maintenance are performed. Coordinate test activities with external testing partners. Perform other TransMedics tasks and duties as assigned/required. MANAGEMENT RESPONSIBILITIES This position manages the following positions on a daily basis. This position will not have management responsibilities. PHYSICAL ATTRIBUTES General Office Environment Ability to lift up to 25 lbs. May travel up to 10% domestically / 10% internationally MINIMUM QUALIFICATIONS BS/MS in Software Engineering, Electrical Engineering, or equivalent combination of education and experience. 10+ years of related experience in real-time embedded software testing. PREFERRED QUALIFICATIONS Experience in planning, managing, and executing software testing activities. Experience in writing software test procedures and conducting software system level testing. Strong knowledge of software in a hardware testing methodology. Experience in an FDA-regulated Class II and/or Class III medical device testing. Experience with embedded systems and integration testing with external systems. Testing experience with Bluetooth/BLE and Cloud-connected devices preferred. Software integration testing and test automation experience is a plus. Experience with requirements and test case management tools. Experience with defect management tools. Experience in an agile development environment is preferred. Medical device software testing experience with compliance to IEC-62304 and FDA guidelines. Every Organ Wasted is a Life Not Saved. TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients' lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health. Maximize your potential at TransMedics, Inc. www.TransMedics.com TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $151,500.00 – $215,700.00, which represents the company's current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history. Employee Benefit: Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA Dental Vision Healthcare Flexible Spending Account Dependent Care Flexible Spending Account Short Term Disability Long Term Disability 401K Plan Pet insurance Employee Stock Purchase Plan 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.