Sr. Principal Systems Engineer

Baxter Healthcare; Milwaukee (WI); On-site; USD 128,000 - 176,000; Full time

Benefits offered by this job

Annual incentive bonus

Reasonable accommodations for disabilities

Job summary

Baxter Healthcare is seeking a Sr. Principal Systems Engineer in Milwaukee, WI to lead the development of medical devices, managing the integration of technical roadmaps and ensuring compliance with regulatory standards.

The ideal candidate will have over 8 years of engineering experience, a Bachelor's degree in a technical field, and knowledge of risk management and safety compliance. The position offers a salary range of $128,000 to $176,000 and requires U.S. work authorization.

Qualifications

• 8+ years of engineering experience on medical devices.
• Ability to make timely decisions with limited information.
• Fundamental understanding of hardware and software engineering.

Responsibilities

• Manage technical roadmap for product families.
• Lead development of design inputs and requirements.
• Coordinate system and design level requirements.

Skills

Systems engineering principles in Agile SAFe framework

Risk management knowledge (ISO 14971)

Safety compliance knowledge (IEC 60601)

MATLAB proficiency

Strong interpersonal skills

Excellent communication

Education

Bachelor’s Degree in Mechanical, Electrical, Software, or Biomedical Engineering

Tools

Azure DevOps

Polarion

TrackWise

Job description

Role Summary

The Sr. Principal Systems Engineer will lead multidisciplinary development of medical devices, defining customer needs, product functionality, architecture, and risk management requirements. The role coordinates cross‑functional teams, drives design, ensures compliance with regulatory standards, and leads the integration of technical and marketing roadmaps.

Responsibilities

• Manage and own the technical roadmap for product families, integrating with Upstream Marketing roadmaps.
• Work with Program Management, Marketing, and customers to plan new development, initiate product changes, and translate market needs into technical product requirements and workflows; serve as liaison for voice of customer.
• Define and scope projects with Engineering Project Management, participating as a member of project teams for the assigned program.
• Lead development of Design Inputs and Digital Interface Requirements.
• Develop user and clinical workflows for requirement analysis.
• Own system architecture decisions.
• Lead engineering resources (Electrical, Mechanical, Software) in decomposing system requirements into derived requirements.
• Resolve competing constraints among inter‑related functions and lead decision making with tools such as decision matrices.
• Resolve interface issues and document theory of operations for complex medical product designs.
• Work with verification engineers to define test strategies, verification plans, and validation plans using requirement tracing.
• Own the Design History File (DHF) and ensure technical product requirements are clearly documented, verified, and validated.
• Ensure usability requirements are incorporated per IEC 62366.
• Lead risk management analysis per IEC 14971, capturing hazards, mitigations, and residual risk.
• Coordinate and review system and design level requirements to meet market needs, serviceability, and manufacturability.
• Act as a critical issue point person, lead product support meetings, participate in CAPA activities, and assist with complaint and post‑market investigations.
• Oversee platform‑based product designs that satisfy needs for multiple portfolios by coordinating shared requirements.

Qualifications

• Bachelor’s Degree in Mechanical, Electrical, Software, Biomedical Engineering or a comparable technical field.
• 8+ years of engineering experience on medical devices.
• Knowledge of ISO 14971 risk management for medical devices.
• Knowledge of IEC 60601 safety compliance.
• Ability to apply systems engineering principles in an Agile SAFe framework, supporting Product Owner activities.
• Experience with MATLAB (MBSE), Azure DevOps, Polarion, and TrackWise preferred.
• Strong interpersonal skills and leadership in a team environment.
• Ability to make timely decisions with limited information and attention to detail.
• Excellent verbal and written communication, especially for clear requirement documentation.
• Strategic problem‑solving skills, organized and able to manage multiple tasks simultaneously.
• Ability to plan, estimate, and track deliverables accurately.
• Fundamental understanding of hardware and software engineering.
• Adaptive, open to change, and continuously looking to simplify work.
• Prior experience with Resting ECG devices (AFE, cardiographs) is a plus.

Compensation

The position offers a salary range of $128,000 to $176,000, with an annual incentive bonus. Compensation may vary based on skills, experience, business line, and location.

Work Authorization

Applicants must be authorized to work for any employer in the U.S.; sponsorship of employment visas is not available.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity, protected veteran status, disability or handicap status, or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to providing reasonable accommodations to individuals with disabilities. If you need an accommodation for any part of the application or interview process, submit a request with contact details.