Senior Software Systems Engineer – Healthcare Tech & AI

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

Benefits offered by this job

Flexible workplace policy

US Benefits

Job summary

Baxter is seeking a Sr. Software Systems Engineer to join the R&D/Software organization. You will contribute to Infusion Pump Platforms and connected ecosystem Digital Applications, driving modern software practices and ensuring regulatory alignment.

As a senior contributor, you will lead architecture, requirements, and verification efforts while mentoring a distributed team. This role emphasizes collaboration, quality, and patient-centered software solutions in a regulated environment.

Qualifications

• Bachelor’s degree in an engineering discipline with 3+ years of experience.
• Experience with regulated products and connected systems in the medical devices/biotechnology industry.
• Experience with cloud-based digital applications; AWS/Azure or similar CSPs preferred.
• Familiarity with electro-mechanical devices is preferred.
• Expertise in requirements management, risk management, and development in an Agile environment, including backlog management.
• Knowledge of implementing medical device cybersecurity design paradigms is a plus.
• Excellent verbal and written communication; strong documentation in regulated environments.

Responsibilities

• Drive Best Practices: Implement and champion best practices in software systems development and product lifecycles with Agile PDLC/SDLC.
• Technical Leadership: Provide guidance and mentorship to a distributed R&D team.
• Complex Problem Solving: Develop innovative technical solutions to complex software system challenges.
• Architectural Contributions: Help establish robust system and software architectures for digital applications.
• User Needs Translation: Capture user needs and translate into system requirements across teams.
• Design Inputs and Compliance: Write and own design inputs/requirements with compliance to QMS and ISO/IEC 62304.
• Risk Management: Lead ISO 14971-based risk analysis activities.
• Verification and Validation: Define test strategies with verification and validation plans.
• Hands-On Testing: Conduct ad-hoc testing to ensure product quality.
• Agile Execution: Enforce and support Agile/Scrum planning and execution.
• Stakeholder Collaboration: Drive collaboration with stakeholders to improve processes and mentorship.
• Design Transfer Process: Interface with manufacturing, field service, and training during design transfer.
• Issue Resolution: Address product complaints with impact assessments on requirements and risks.
• Compliance Assurance: Ensure compliance with product development processes and quality systems.

Skills

Regulated products

Cloud-based apps

Electro-mechanical devices

Requirements management

Agile development

Medical device cybersecurity

Communication skills

Regulated industry documentation

Education

Bachelor’s degree in engineering

Job description

Baxter is seeking a Sr. Software Systems Engineer to join the R&D/Software organization. You will contribute to Infusion Pump Platforms and connected ecosystem Digital Applications, driving modern software practices and ensuring regulatory alignment.

As a senior contributor, you will lead architecture, requirements, and verification efforts while mentoring a distributed team. This role emphasizes collaboration, quality, and patient-centered software solutions in a regulated environment.