Sr. Principal Systems Engineer

Sr. Principal Systems Engineer This is where your work saves lives. The research we do and the products we develop improve outcomes for patients around the world. As a Sr. Principal Systems Engineer at Baxter, your work contributes directly to making a significant impact on others. It's challenging work—and you're not on your own. Our teams collaborate cross-functionally and lead by influence. Our colleagues within our R&D organization desire to work on products that make a meaningful difference in others' lives. We are motivated by the power of teamwork and are natural leaders who are skilled at influencing others! As a Sr. Principal Systems Engineer, you will be a part of a multidisciplinary new product development team! This position will understand and define customer needs; product functionality and performance requirements; product architecture, constraints and trade-offs; design and interface requirements, of new products being developed. You will support the overall design of the final product and responsible for all risk management activities to ensure a safe and effective product. The Team While everyone at Baxter has a shared passion for our mission, the R&D teams play a meaningful role in our ability to save and sustain lives. Scientists and engineers in R&D work together to develop, test, and launch products that enhance patient care. What You'll Be Doing Manage and own the technical roadmap for product families, integrate technical roadmaps with Upstream Marketing product roadmaps Work with Program Management, Upstream Marketing and Customers to plan new development, initiate product change activities, understand & translate market needs into technical product requirements & workflows. Work with cross functional team members (e.g., Marketing and Clinical personnel) to translate user needs into system requirements. Serve as liaison VOC from Marketing to Engineering. Work with Engineering Project Management to define and scope projects to achieve program goals. Participate as a member of project teams for the assigned program. Lead development of Design Inputs and Digital Interface Requirements. Develop User and Clinical Workflows to drive requirement analysis Own System Architecture Lead engineering resources (Electrical, Mechanical, and Software) in the decomposition of system requirements to derived requirements. Contributes to resolution of competing constraints among inter-related functions (e.g., engineering, manufacturing, regulatory, marketing) required to deliver products to market. Lead Decision Making using tools such as Decision Matrices to evaluate trade-offs. Resolves interface issues and have the ability to document theory of operations of complex medical product designs. Work with verification engineers to define test strategies for the development of verification plans and validation plans using requirement tracing methods. Owner of the Design History File (DHF). Responsible for ensuring technical product requirements are clearly & thoroughly documented, and verified & validated. This includes the following: Ensures usability requirements are adequately incorporated per IEC 62366. Lead technical resource for Risk Management analysis activities per IEC 14971 including capturing hazards, mitigations, and residual risk determination. Lead Coordination and review of system and design level requirements to ensure they adequately meet system requirements, market needs, serviceability and manufacturability of the product. Member of multi-functional support team; duties as needed include serving as critical issue point-person, lead product support meetings, participate in CAPA activities, asist with complaint & post-market investigations. Oversee platform-based product designs that meet needs for multiple portfolios by coordinating shared needs and requirements. What You'll Bring Bachelor's Degree (Mechanical, Electrical, Software, Biomedical Engineering or comparable technical subject area) 8+ years' of engineering experience on medical devices. Knowledge in ISO 14971 Application of Risk Management to Medical Devices Knowledge of IEC 60601 Safety Compliance of Medical Devices Ability to apply systems engineering principles in Agile SAFe framework by supporting the Product Owner in Epic, Feature and Story development/definition and backlog prioritization Experience using tools such as MATLAB (MBSE), Azure DevOps, Polarion, Trackwise preferred. Strong interpersonal skills with the ability to lead and work collaboratively with others in a team environment Able to work in the absence of complete information and make timely decisions performing with great attention to detail Excellent verbal and written communication, especially relating to clear, concise, and verifiable requirements. Strategic problem solver, organized and able to progress on many different tasks in parallel Able to plan, estimate and accurately track deliverables Fundamental understanding of Hardware & Software engineering Adaptive, open to change and continuously looks for ways to improve and simplify sophisticated work Prior experience on Resting ECG devices (AFE, Cardiographs) is a plus. 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. We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. To that end, this position has a salary range of $128,000 to $176,000 and also includes an annual incentive bonus. The above range represents the expected salary range for the position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in role, business line, and geographic/office location. Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. Baxter