Sr. Software Systems Engineer

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

Sr. Software Systems Engineer

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!

What You'll Be Doing

As a Senior Software Systems Engineer, your responsibilities will include:

• 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.
• Desing 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.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 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. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

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.

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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