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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Principal Software Systems Engineer - **Company:** Baxter International Inc. - **Location:** Raleigh, NC, United States - **Experience:** Expert - **Salary:** $144,000.0 - $198,000.0 - **Contract:** Permanent contract - **Skills:** Agile Methodology, Artificial Intelligence, Amazon Web Services, Microsoft Azure, Software as a Service, Cloud Computing, Infrastructure as a Service (IaaS), Platform as a Service (PAAS), Scrum Methodology, Software Architecture, Requirements Management, Software Requirements Analysis, Software Systems, Verification and Validation (Software), Software Verification - **Published:** October 8, 2026 - **Apply:** https://baxter.wd1.myworkdayjobs.com/baxter/job/Raleigh-North-Carolina/Sr-Principal-Software-Systems-Engineer---Relocation-Assistance_JR-210068-1/apply ## About the Role * A Bachelor's degree in an engineering discipline with 10+ years of experience, or a Master's degree with 8+ years of experience. * Proven experience with regulated products and connected systems in the medical devices/biotechnology industry. * Experience with cloud-based digital applications is preferred. (e.g. SaaS/PaaS/IaaS environments with AWS/Azure or similar CSPs). Experience with implementing AI/ML paradigms in Digital Applications a plus. * Familiarity with electro-mechanical devices is preferred. * Expertise in requirements management, risk management, and development in an Agile environment, including experience in creating and maintaining product backlogs. * Knowledge of implementing and enforcing medical device cybersecurity design paradigms is a plus. * Exceptional oral and written communication skills. * Strong documentation skills and experience in a regulated industry. ## Description As a Senior Principal Software Systems Engineer, your responsibilities will include: * Driving Best Practices: Implement and champion best practices in software systems development and product lifecycles, utilizing Agile PDLC/SDLC and Systems Engineering methodologies in collaboration with development and verification teams. Utilize AI (prompt engineering, agentic AI, AI extensions on existing tools, etc.) to implement rapid requirements and risk prototyping, while maintaining quality and accuracy. * Technical Leadership: Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence. * Complex Problem Solving: Develop innovative technical solutions to complex software system challenges, delivering high-quality results within tight deadlines. * Architectural Contributions: Assist in establishing robust system and software architectures for digital applications, ensuring alignment with established design inputs. Ensure systems of systems and interoperability considerations are accounted for and represented in the architectures. * ·User Needs Translation: Identify and capture user needs for digital applications, translating them into functional and non-functional system requirements. Lead cross-functional teams to ensure these needs are effectively integrated into system requirements. * Desing Inputs and Compliance: Write, maintain, and own system-level and software-level design inputs/requirements, ensuring compliance with established Quality Management Systems (QMS) and regulatory frameworks such as ISO 13485 and IEC 62304. * Risk Management: Lead ISO 14971-based risk analysis activities, from identifying inherent hazards to implementing effective mitigation strategies. * Verification and Validation: Collaborate with verification engineers to define test strategies for system and software verification and validation plans, utilizing requirement tracing methods. * Hands-On Testing: Conduct ad-hoc testing of in-development and developed software systems to ensure ongoing product quality. * Agile Execution: Enforce and support teams in executing Agile/Scrum planning, including estimating, scheduling, and completing committed tasks. * Stakeholder Collaboration: Drive collaboration with internal and external stakeholders to enhance processes, practices, and technical mentorship, transforming software requirements into effective test architectures. * Design Transfer Process: Interface with manufacturing, field service, operations, and customer training staff throughout the design transfer process. * Issue Resolution: Ensure that product complaints and issues are addressed promptly, with appropriate impact assessments on requirements and risks. * Compliance Assurance: Uphold compliance with the product development process and quality system standards., If you are a passionate and innovative software systems engineer eager to shape the future of healthcare technology, we want to hear from you! Join us in our mission to develop best-in-class standards and practices that will revolutionize patient care and enhance the lives of countless individuals. Your expertise will directly contribute to creating solutions that save and sustain lives. Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.