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# Principal Systems Engineer

- **Company:** Baxter
- **Location:** Skaneateles, NY, United States
- **Salary:** $112,000.0 - $154,000.0
- **Contract:** Permanent contract
- **Skills:** Systems Engineering, Software Engineering
- **Published:** June 5, 2026
- **Apply:** https://www.careerjet.com/jobad/us7aef28a73c0c0e0058d17471988d22e8

## About the Role

Bachelor's degree in Mechanical, Electrical, Software Engineering, or a related technical discipline
5+ years of relevant engineering experience, preferably in medical devices or a regulated industry
Strong working knowledge of:
ISO 14971 (Application of Risk Management to Medical Devices)
IEC 62304 (Medical Device Software Lifecycle Processes)
IEC/TR 80002-1 (Guidance on Software Risk Management)
Demonstrated ability to lead through influence in a cross-functional team environment
Strong interpersonal and communication skills, with the ability to clearly convey complex technical concepts
Ability to make sound decisions in the absence of complete information and navigate ambiguity effectively
Strategic mindset with strong attention to detail and execution discipline
Proven ability to manage multiple priorities and deliverables in parallel
Strong problem-solving and critical-thinking skills
Experience planning, estimating, and tracking technical work
Solid understanding of both hardware and software development processes
Demonstrated ability to write clear, concise, and verifiable requirements
Adaptable and continuous improvement-oriented mindset, with a focus on simplifying complex processes
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.

## Description

Translate customer needs, business objectives, and regulatory requirements into clear, testable system-level requirements
Lead and execute risk management activities in accordance with ISO 14971 (Medical Device Risk Management Standard), including:
Risk management planning
Risk analysis and evaluation
Risk control implementation and verification
Decompose system-level requirements into subsystem and module-level requirements, ensuring traceability
Plan and oversee reliability and robustness activities to ensure product performance over time
Lead cross-functional teams in identifying and mitigating technical risks, resolving issues, and managing test defects
Evaluate product and design changes holistically to ensure impacts are fully assessed across system, regulatory, and business dimensions
Drive alignment across engineering, quality, and regulatory functions on system-level decisions and deliverables
Support adherence to Baxter product development processes, documentation expectations, and regulatory requirements
What You'll Bring


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