Sr. Principal Systems Engineer,

About the role

This is where your work saves lives
At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Success Profile

What makes a successful Research and Development team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.
Courage
Action Oriented
Collaborates
Cultivates Innovation
Manages Ambiguity
Drives Results

Your Role at Baxter

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.

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, assist 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.