Senior Software Systems Engineer, Healthcare Platforms

Baxter International Inc.

Raleigh (NC)

Hybrid

USD 104,000 - 143,000

Full time

8 days ago

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Benefits offered by this job

Flexible workplace policy

Health and dental coverage from dayone

401(k) with company matching

Employee Stock Purchase Plan (ESPP)

Job summary

Baxter International Inc. is seeking a Senior Software Systems Engineer to join the R&D/Software organization, driving development of groundbreaking healthcare solutions within Infusion Pump Platforms and connected digital applications.

You will lead design and verification activities, ensure regulatory compliance, and translate user needs into robust system requirements. Ideal candidates will bring a strong background in Agile execution, systems engineering, and experience with regulated

Qualifications

Bachelor’s degree in engineering with 3+ years of experience.
Regulated products and connected systems in medical devices/biotechnology industry.
Cloud-based digital applications experience with AWS/Azure or similar CSPs; AI/ML in Digital Applications a plus.
Experience with electro-mechanical devices preferred.
Expertise in requirements management, risk management, and Agile development with backlogs.
Knowledge of medical device cybersecurity design paradigms is a plus.
Excellent oral and written communication skills.
Strong documentation skills in a regulated industry.

Responsibilities

Drive best practices in software system development and product lifecycles using Agile PDLC/SDLC and Systems Engineering methodologies; incorporate AI/agentic approaches where appropriate.
Provide technical leadership to a distributed R&D team.
Develop innovative solutions to complex software system challenges.
Assist in establishing robust system and software architectures for digital applications.
Translate user needs into functional and non-functional requirements; lead cross-functional teams.
Write and own system/software design inputs; ensure compliance with QMS and regulatory frameworks.
Lead ISO 14971-based risk analysis activities.
Define verification/validation test strategies; collaborate on traceability.
Conduct ad-hoc testing to ensure ongoing quality.
Enforce Agile/Scrum planning, estimates, scheduling, and delivery.
Collaborate with stakeholders to improve processes and provide mentorship.
Interface with manufacturing, field service, operations, and training during design transfer.
Address product complaints with impact assessments on requirements and risks.
Uphold compliance with product development processes and quality systems.