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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.
Job Responsibility
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.
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.
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).
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
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.
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
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
Nice to have
Experience using tools such as MATLAB (MBSE), Azure DevOps, Polarion, Trackwise preferred.
Prior experience on Resting ECG devices (AFE, Cardiographs) is a plus.
What we offer
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave