Senior Software Systems Engineer – Healthcare Platforms

Baxter International Inc.; Raleigh (NC); Hybrid; USD 144,000 - 198,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

401(k) with company match

ESPP

Job summary

Baxter International Inc. is seeking a Senior Principal Software Systems Engineer to drive development of digital applications within the Infusion Pump Platforms and connected ecosystem.

You will lead architecture, ensure ISO 13485 and IEC 62304 compliance, oversee ISO 14971 risk analyses, and guide agile execution across distributed teams while delivering high-quality software solutions for healthcare products.

Qualifications

• Bachelor’s degree in an engineering discipline with 10+ years of experience, or a Master’s degree with 8+ years of experience.
• Experience with regulated products and connected systems in medical devices/biotechnology.
• Experience with cloud-based digital applications (AWS/Azure) and AI/ML paradigms in digital applications is a plus.
• Familiarity with electro-mechanical devices is preferred.
• Expertise in requirements management, risk management, and agile development, including backlog creation/maintenance.
• Knowledge of medical device cybersecurity design paradigms is a plus.
• Exceptional written and verbal communication; strong documentation in regulated environments.

Responsibilities

• Drive best practices in software systems development and product lifecycles using Agile PDLC/SDLC and Systems Engineering.
• Provide technical leadership to a distributed R&D team and foster innovation.
• Develop solutions to complex software system challenges delivering quality within deadlines.
• Help establish robust system/software architectures for digital applications with interoperability considerations.
• Translate user needs into functional/non-functional requirements and lead cross-functional implementation.
• Write and own system/software design inputs ensuring compliance with QMS/regulatory standards.
• Lead ISO 14971 risk analysis from hazard identification to mitigation.
• Define test strategies for verification/validation with traceability.
• Conduct ad-hoc testing to ensure ongoing product quality.
• Enforce Agile/Scrum planning, estimation, and execution.
• Collaborate with stakeholders to improve processes and mentor teams.
• Interface with manufacturing/field service during design transfer.

Skills

Agile methodologies

Systems engineering

Technical leadership

Architectural design

Requirements translation

Regulatory compliance

Risk management

Verification & validation

Hands-on testing

Agile execution

Stakeholder collaboration

Design transfer

Issue resolution

Quality systems

Education

Bachelor’s degree in engineering or related field

Master’s degree in engineering

Tools

AWS

Azure

Job description

Baxter International Inc. is seeking a Senior Principal Software Systems Engineer to drive development of digital applications within the Infusion Pump Platforms and connected ecosystem.

You will lead architecture, ensure ISO 13485 and IEC 62304 compliance, oversee ISO 14971 risk analyses, and guide agile execution across distributed teams while delivering high-quality software solutions for healthcare products.