Senior Software Systems Engineer - MedTech AI Platforms

Baxter International; Raleigh (NC); Hybrid; USD 104,000 - 143,000; Full time

Benefits offered by this job

Medical and dental coverage

401(k) plan

Employee Stock Purchase Plan (ESPP)

Paid holidays and PTO

Job summary

Baxter International is seeking a Senior Software Systems Engineer to lead the R&D/Software team, focusing on Infusion Pump Platforms and connected Digital Applications. You will drive architectural decisions, ensure regulatory compliance, and mentor a distributed team to deliver high-quality healthcare software solutions.

The role emphasizes Agile execution, design inputs, risk management, and hands-on testing to meet customer needs while adhering to ISO 13485 and IEC 62304 standards.

Qualifications

• Bachelor’s degree in engineering with 3+ years of experience.
• Experience with regulated medical devices or biotechnology.
• Cloud-based digital applications experience (AWS/Azure) preferred.
• Experience in Agile environments and product backlogs.

Responsibilities

• Drive best practices in software systems development and product lifecycles with Agile PDLC/SDLC and Systems Engineering.
• Provide technical leadership to a distributed R&D team.
• Solve complex software system problems with innovative solutions.
• Contribute to robust system and software architectures for digital applications.
• Translate user needs into functional requirements and lead cross-functional teams.
• Write and own system/software design inputs and ensure QMS and regulatory compliance.
• Lead ISO 14971 risk analysis and mitigation strategies.
• Collaborate on test strategies for verification and validation.

Skills

Agile/SDLC

Systems Engineering

Technical Leadership

Requirements Management

Quality & Regulatory

Risk Management

Verification & Validation

AI/ML in Software

Education

Bachelor's degree in Engineering

Tools

AWS

Azure

Job description

Baxter International is seeking a Senior Software Systems Engineer to lead the R&D/Software team, focusing on Infusion Pump Platforms and connected Digital Applications. You will drive architectural decisions, ensure regulatory compliance, and mentor a distributed team to deliver high-quality healthcare software solutions.

The role emphasizes Agile execution, design inputs, risk management, and hands-on testing to meet customer needs while adhering to ISO 13485 and IEC 62304 standards.