Sr. Software Systems Engineer

Baxter • Raleigh, NC

2d • Hybrid

About The Position

Baxter is hiring a Senior Software Systems Engineer in its R&D/Software organization. The role supports new product development and sustaining activities for Infusion Pump Platforms and the connected ecosystem Digital Applications group, helping deliver customer-focused healthcare solutions while meeting regulatory requirements. The position applies software systems development, product lifecycle, Agile, and Systems Engineering practices, and contributes to product architecture, requirements, risk management, verification, validation, testing, and design transfer. The position follows Baxter’s flexible workplace policy, which requires a minimum number of days onsite each week.

The engineer will provide technical leadership to a distributed R&D team and collaborate with development, verification, manufacturing, field service, operations, customer training, and other internal and external stakeholders. The role owns and maintains system- and software-level requirements, supports compliance with quality management systems and medical-device regulations, and helps address product complaints and issues. The estimated base salary is $104,000 to $143,000 annually; the position may also be eligible for discretionary bonuses. Applicants must be authorized to work for any U.S. employer; visa sponsorship is not available.

Requirements

• Bachelor’s degree in an engineering discipline.
• At least 3 years of experience.
• Proven experience with regulated products and connected systems in the medical devices or biotechnology industry.
• Expertise in requirements management, risk management, and development in an Agile environment, including creating and maintaining product backlogs.
• Exceptional oral and written communication skills.
• Strong documentation skills and experience in a regulated industry.
• Authorization to work for any employer in the United States; visa sponsorship is unavailable.

Nice To Haves

• Experience with cloud-based digital applications, such as SaaS/PaaS/IaaS environments using AWS, Azure, or similar cloud service providers.
• Experience implementing AI/ML paradigms in digital applications.
• Familiarity with electromechanical devices.
• Knowledge of implementing and enforcing medical-device cybersecurity design paradigms.

Responsibilities

• Champion software systems development and product lifecycle best practices using Agile PDLC/SDLC and Systems Engineering methods in collaboration with development and verification teams.
• Use AI, including prompt engineering, agentic AI, and AI extensions to existing tools, for rapid requirements and risk prototyping while maintaining quality and accuracy.
• Provide guidance, mentorship, and technical leadership to a distributed R&D team.
• Develop technical solutions to complex software system challenges and deliver results within tight deadlines.
• Assist in establishing system and software architectures for digital applications, aligning them with design inputs and accounting for systems-of-systems and interoperability considerations.
• Identify and capture user needs for digital applications, translate them into functional and non-functional system requirements, and lead cross-functional integration of those needs.
• Write, maintain, and own system- and software-level design inputs and requirements in compliance with quality management systems and applicable regulatory frameworks.
• Lead risk analysis based on ISO 14971, identifying hazards and implementing mitigation strategies.
• Collaborate with verification engineers to define test strategies for system and software verification and validation plans, using requirements tracing methods.
• Conduct ad-hoc testing of software systems in development and completed systems.
• Support Agile/Scrum planning, including estimating, scheduling, and completing committed tasks.
• Collaborate with stakeholders to improve processes, practices, and technical mentorship, and translate software requirements into effective test architectures.
• Interface with manufacturing, field service, operations, and customer training staff during design transfer.
• Ensure product complaints and issues are addressed promptly and assess impacts on requirements and risks.
• Uphold compliance with the product development process and quality system standards.

Benefits

• Medical and dental coverage starting on day one.
• Basic life, accident, short-term disability, long-term disability, and business travel accident insurance.
• Employee Stock Purchase Plan with the ability to purchase company stock at a discount.
• 401(k) Retirement Savings Plan with employee contributions and company matching.
• Flexible Spending Accounts.
• Educational assistance programs.
• Paid holidays.
• Paid time off ranging from 20 to 35 days based on length of service.
• Family and medical leaves of absence.
• Paid parental leave.
• Commuting benefits.
• Employee Discount Program.
• Employee Assistance Program.
• Childcare benefits.
• The position may be eligible for discretionary bonuses.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior