Senior Software Systems Engineer - AI-Driven MedTech

Baxter International Inc.; Raleigh (NC); On-site; USD 104,000 - 143,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Employee stock purchase program (ESPP)

Paid time off

Job summary

Baxter International Inc. seeks a Senior Software Systems Engineer for its R&D/Software group in the US.

You will help develop groundbreaking healthcare solutions, lead software and system architecture discussions, and ensure regulatory alignment across Infusion Pump Platforms and connected digital applications. You will drive best practices, provide technical leadership, and collaborate with cross-functional teams to translate user needs into robust requirements and test strategies.

Qualifications

• Bachelor’s degree in an engineering discipline; 3+ years experience.
• Experience with regulated medical devices and connected systems.
• Experience with cloud-based digital applications (AWS/Azure or similar).
• AI/ML paradigms in Digital Applications is a plus.
• Familiarity with cybersecurity design paradigms for medical devices is a plus.
• Excellent written and oral communication in a regulated industry.

Responsibilities

• Drive best practices in software systems development and life cycles.
• Provide technical leadership to a distributed R&D team.
• Develop innovative software solutions for complex challenges.
• Assist in establishing robust system and software architectures.
• Translate user needs into functional and non-functional requirements.
• Write and maintain design inputs/requirements compliant with QMS and regulatory standards.
• Lead risk analysis and mitigation per ISO 14971.
• Define test strategies for system/software verification and validation.
• Conduct ad-hoc testing to ensure product quality.
• Enforce Agile/Scrum planning, estimation, and scheduling.
• Collaborate with stakeholders to enhance processes and mentorship.
• Interface with manufacturing and service teams during design transfer.
• Address product complaints with impact assessments on requirements and risks.
• Ensure compliance with product development processes and quality systems.

Skills

Bachelor's degree in engineering

Regulated medical devices experience

Cloud-based digital apps experience

AI/ML in Digital Applications

Regulatory knowledge (ISO 13485, IEC ?

Cybersecurity for medical devices

Agile/Scrum experience

Excellent communication

Education

Bachelor’s degree in an engineering discipline

Job description

Baxter International Inc. seeks a Senior Software Systems Engineer for its R&D/Software group in the US.

You will help develop groundbreaking healthcare solutions, lead software and system architecture discussions, and ensure regulatory alignment across Infusion Pump Platforms and connected digital applications. You will drive best practices, provide technical leadership, and collaborate with cross-functional teams to translate user needs into robust requirements and test strategies.