Senior Principal Systems Engineer

Baxter International Inc.

Sr. Principal Systems Engineer impacting healthcare through R&D.

Posted 7/8/2026full-timeMilwaukee • Illinois, New York, Wisconsin • 🇺🇸 United StatesSenior💰 $128,000 - $176,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing technical roadmaps and translating market needs into technical product requirements for medical devices. Proficient in risk management, system architecture, and leading cross-functional teams to ensure compliance with industry standards.

Highest-signal resume keywords

Medical Device Engineering ExperienceISO 14971 Risk Management KnowledgeIEC 60601 Safety Compliance KnowledgeAgile SAFe Framework ApplicationUser and Clinical Workflow Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Systems Engineering PrinciplesTechnical Requirement DocumentationDesign History File ManagementVerification and Validation PlanningDigital Interface Requirements Development

Soft Skills

Strong Interpersonal SkillsStrategic Problem SolvingAttention to DetailExcellent Communication SkillsTeam Collaboration

Tools & Technologies

MATLAB (MBSE)Azure DevOpsPolarionTrackwise

Industry Keywords

Medical DevicesUsability Requirements (IEC 62366)Hardware EngineeringSoftware EngineeringResting ECG Devices

Tech Stack

Tools & technologies

Azure

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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.

Benefits

Comp & perks

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)
401(k) Retirement Savings Plan (RSP)
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
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
Childcare benefits