Senior Principal Software Systems Engineer (Medical Devices)

Baxter International; Raleigh (NC); On-site; USD 144,000 - 198,000; Full time

Benefits offered by this job

Health and dental coverage that starts

401(k) Retirement Savings Plan

Employee Stock Purchase Plan (ESPP)

Paid time off

Job summary

Baxter International is seeking a Sr. Principal Software Systems Engineer in Raleigh, NC, to drive advanced software systems for infusion pump platforms and connected digital applications. You will lead cross-functional teams, ensure regulatory compliance, and shape architecture and risk management across the product lifecycle.

The role demands deep expertise in Agile practices, requirements management, and collaboration with manufacturing and service teams, with relocation assistance provided.

Qualifications

• 10+ years of engineering experience or 8+ years with a Master’s degree.
• Experience with regulated medical device products and connected systems.
• Cloud-based digital applications experience (AWS/Azure) preferred.
• Proficient in Agile/PDLC/SDLC and risk management.
• Strong documentation and communication in a regulated environment.

Responsibilities

• Lead software systems engineering across Infusion Pump Platforms and digital apps.
• Define system requirements and ensure ISO 13485/IEC 62304 compliance.
• Drive risk management and verification/validation planning.
• Provide technical leadership to a distributed R&D team.
• Collaborate with stakeholders and manage design transfer to manufacturing.

Skills

Best practices

Technical leadership

Complex problem solving

Architectural contributions

User needs translation

Design inputs/compliance

Risk management

Verification & validation

Hands-on testing

Agile execution

Stakeholder collaboration

Design transfer

Issue resolution

Regulatory compliance

Education

Bachelor's in engineering

Master's degree

Tools

AWS

Azure

Job description

Baxter International is seeking a Sr. Principal Software Systems Engineer in Raleigh, NC, to drive advanced software systems for infusion pump platforms and connected digital applications. You will lead cross-functional teams, ensure regulatory compliance, and shape architecture and risk management across the product lifecycle.

The role demands deep expertise in Agile practices, requirements management, and collaboration with manufacturing and service teams, with relocation assistance provided.