This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission. Your Role at Baxter Do you want to use your Software Quality Engineer skills to make a difference in the world of Cardiology? Bardy Diagnostics is an exciting, fast growing organization within Baxter with a unique and compelling product looking for a strong Sr. Principal Software Quality Engineer to help us achieve our mission! Join a multi-skilled team dedicated to developing innovative wearable cardiac arrhythmia monitors and associated cloud-based and supporting software. In this role, you'll work in a small and dedicated team passionate about the development of these products and supporting software. The ideal candidate will be motivated by the unique challenges and opportunities of a fast-growing medical device organization, by solving sophisticated technical problems, and have a penchant for continuous improvement and Quality Engineering excellence. What you will be doing Provide technical and strategic feedback associated with medical device software (SaMD and SiMD), digital health, and cybersecurity aligned with applicable regulations, standards, and business needs. Establish and cultivate positive relationships with cross-functional stakeholders and product development team members to optimize the success of development projects. Lead the development and maintenance of the Risk Management File (RMF) including risk management plans, hazards analysis, dFMEAs, pFMEAs, and risk management report. Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation. Responsible for quality oversight and approval of software product development plans, design inputs and outputs, verification and validation, and review of test planning, protocols, and reports. Provide guidance on statistical methods and analyses for design verification and validation, including test method validation. Serve as the SME for software quality and collaborate with teams on code reviews, software security analysis, defect and vulnerability triage, creation and maintenance of sBOMs, etc., and lead implementation of best practices for software quality processes. Participate in design reviews to ensure the effective development, transfer, and maintenance of the product throughout the product lifecycle. Support the successful transfer and hyper-care phase of design and design modifications into production/field deployment. Support/lead non-product software assessments and qualification efforts. Lead changes to the Quality System based on new regulations, mentorship documents, industry standards, and observations. Own the resolution and timely closure of CAPAs as they relate to the design control process. Follow documented procedures for all activities related to the Company's Quality System. Support other areas of the Quality System and perform other tasks as defined by Management. What do you bring B.S./M.S. in relevant engineering field (e.g., biomedical, computer science, software, electrical, etc.) or equivalent scientific degree. Minimum of eight (8) plus years of progressive Quality Engineering experience in the medical device industry with hands-on support for software