Sr. Software Systems Engineer

Zvh; Raleigh (NC); On-site; USD 104,000 - 143,000; Full time

Benefits offered by this job

Medical and dental coverage

401(k) with ESPP

Paid holidays and PTO 20–35 days

Job summary

Baxter is seeking a Senior Software Systems Engineer to join our R&D/Software group and help develop groundbreaking healthcare solutions for infusion pump platforms and connectedDigital Applications. You will drive best practices, utilize AI techniques, and lead a distributed team while ensuring regulatory compliance and high quality.

Responsibilities include defining system requirements, architecture, risk analysis, and verification/validation planning in a regulated environment.

Qualifications

• Bachelor’s degree in engineering with 3+ years of experience.
• Experience with regulated medical devices/biotechnology.
• Experience with cloud-based digital applications (AWS/Azure).
• Experience applying AI/ML in digital applications is a plus.
• Strong documentation skills and regulatory compliance knowledge.

Responsibilities

• Drive best practices in software systems development and product lifecycles using Agile PDLC/SDLC and Systems Engineering.
• Lead AI-driven prototyping and implement rapid requirements while ensuring quality.
• Provide technical leadership to a distributed R&D team.
• Develop innovative solutions for complex software system challenges, meeting deadlines.
• Contribute to robust system architectures for digital applications with regulatory alignment.
• Translate user needs into system requirements and lead cross-functional integration.
• Write and own design inputs/requirements ensuring ISO 13485 and IEC 62304 compliance.
• Lead ISO 14971-based risk analysis and mitigation activities.
• Define test strategies for system/software verification and validation.
• Conduct ad-hoc testing to ensure product quality.
• Enforce Agile/Scrum planning and timely delivery.
• Collaborate with stakeholders to improve processes and mentorship.
• Interface with design transfer to manufacturing and service teams.
• Address product issues with impact assessments on requirements and risks.
• Ensure compliance with product development processes and quality systems.

Skills

Regulated product development

Cloud-based apps

AI/ML in digital apps

Requirements management

Risk management

Agile/Scrum

Communication skills

Documentation in regulated industry

Education

Bachelor’s degree in engineering

Tools

AWS/Azure

Job description

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.

Your role at Baxter Join our dynamic team as a Senior Software Systems Engineer in the R&D/Software organization, where you will play a pivotal role in developing groundbreaking healthcare solutions. You will be at the forefront of new product development and sustaining activities within our Infusion Pump Platforms and connected ecosystem Digital Applications group, ensuring we meet customer needs while adhering to the highest regulatory standards. If you are passionate about transforming healthcare technology and eager to make a significant impact, this is the opportunity for you!

The estimated base salary for this position is $104,000 to $143,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

What You'll Be Doing

• Driving Best Practices: Implement and champion best practices in software systems development and product lifecycles, utilizing Agile PDLC/SDLC and Systems Engineering methodologies in collaboration with development and verification teams.
• Utilize AI (prompt engineering, agentic AI, AI extensions on existing tools, etc.) to implement rapid requirements and risk prototyping, while maintaining quality and accuracy.
• Technical Leadership: Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence.
• Complex Problem Solving: Develop innovative technical solutions to complex software system challenges, delivering high-quality results within tight deadlines.
• Architectural Contributions: Assist in establishing robust system and software architectures for digital applications, ensuring alignment with established design inputs.
• Ensure systems of systems and interoperability considerations are accounted for and represented in the architectures.
• User Needs Translation: Identify and capture user needs for digital applications, translating them into functional and non-functional system requirements.
• Lead cross-functional teams to ensure these needs are effectively integrated into system requirements.
• Design Inputs and Compliance: Write, maintain, and own system-level and software-level design inputs/requirements, ensuring compliance with established Quality Management Systems (QMS) and regulatory frameworks such as ISO 13485 and IEC 62304.
• Risk Management: Lead ISO 14971-based risk analysis activities, from identifying inherent hazards to implementing effective mitigation strategies.
• Verification and Validation: Collaborate with verification engineers to define test strategies for system and software verification and validation plans, utilizing requirement tracing methods.
• Hands-On Testing: Conduct ad-hoc testing of in-development and developed software systems to ensure ongoing product quality.
• Agile Execution: Enforce and support teams in executing Agile/Scrum planning, including estimating, scheduling, and completing committed tasks.
• Stakeholder Collaboration: Drive collaboration with internal and external stakeholders to enhance processes, practices, and technical mentorship, transforming software requirements into effective test architectures.
• Design Transfer Process: Interface with manufacturing, field service, operations, and customer training staff throughout the design transfer process.
• Issue Resolution: Ensure that product complaints and issues are addressed promptly, with appropriate impact assessments on requirements and risks.
• Compliance Assurance: Uphold compliance with the product development process and quality system standards.

What You'll Bring

• A Bachelor’s degree in an engineering discipline with 3+ years of experience
• Proven experience with regulated products and connected systems in the medical devices/biotechnology industry.
• Experience with cloud-based digital applications is preferred. (e.g. SaaS/PaaS/IaaS environments with AWS/Azure or similar CSPs).
• Experience with implementing AI/ML paradigms in Digital Applications a plus.
• Familiarity with electro-mechanical devices is preferred.
• Expertise in requirements management, risk management, and development in an Agile environment, including experience in creating and maintaining product backlogs.
• Knowledge of implementing and enforcing medical device cybersecurity design paradigms is a plus.
• Exceptional oral and written communication skills.
• Strong documentation skills and experience in a regulated industry.

Why Join Us?

If you are a passionate and innovative software systems engineer eager to shape the future of healthcare technology, we want to hear from you! Join us in our mission to develop best-in-class standards and practices that will revolutionize patient care and enhance the lives of countless individuals. Your expertise will directly contribute to creating solutions that save and sustain lives.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.