Enable America Jobs

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 In this role you will partner with development teams and cross-functional stakeholders to support the development of design control, risk management, and compliance deliverables associated with new product development of medical device software, digital health products, cloud-based systems, and AI/ML algorithm-based products. What You'll be doing Partner with development teams and cross-functional stakeholders to provide technical and strategic feedback associated with the development of medical device software (SaMD and SiMD), digital health products, cloud-based systems, AI/ML algorithms and cybersecurity aligned with applicable regulations, standards, and business needs. Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated design control documentation for medical device software. Responsible for quality oversight and approval of software product development plans, risk management, design inputs and outputs, verification and validation, and review of test planning, protocols, and reports. Lead activities for establishing, implementing, and maintaining medical device software Risk Management Files (RMF), including analyzing and evaluating risks, controlling identified risks, and monitoring the effectiveness of the risk control measures. Establish and cultivate positive relationships with cross-functional stakeholders and product development team members to optimize the success of development projects. 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. Complete other duties as assigned. What you'll bring B.S./M.S. in relevant engineering field (e.g., biomedical, computer science, software, electrical, etc.) or equivalent scientific degree. Minimum of 10+ plus years of progressive Quality Engineering experience in the medical device industry with hands-on support for software development. Experience supporting development of medical device software (SaMD and SiMD), digital health products, cloud-based systems, and AI/ML algorithms. Experience supporting the development of des