Sr. Principal Software Systems Engineer - Relocation Assistance

Baxter International Inc.; Raleigh (NC); Hybrid; USD 144,000 - 198,000; Full time

Benefits offered by this job

Medical and dental coverage starting1

401(k) with company match

Employee Stock Purchase Plan (ESPP)

Educational assistance

Paid time off 20+ days and holidays

Job summary

Baxter International Inc. is seeking a Senior Principal Software Systems Engineer to lead development and sustaining activities for Infusion Pump Platforms and connected digital applications.

You will guide best practices across Agile PDLC/SDLC, mentor a dispersed R&D team, and design architectures that ensure interoperability and regulatory compliance. You will translate user needs into robust requirements, drive risk management per ISO 14971, and collaborate with verification and manufacturing

Qualifications

• Bachelor’s degree in engineering with 10+ years of experience or Master’s degree with 8+ years of experience in a related field.
• Experience with regulated medical devices/biotechnology.
• Experience with cloud-based digital applications (AWS/Azure or similar CSPs).
• Experience implementing AI/ML paradigms in Digital Applications is a plus.
• Familiarity with electro-mechanical devices is preferred.
• Expertise in requirements management, risk management, and Agile development.
• Knowledge of medical device cybersecurity design paradigms is a plus.
• Excellent oral and written communication skills.
• Strong documentation in a regulated industry.

Responsibilities

• Drive best practices in software systems development and product lifecycles using Agile PDLC/SDLC and Systems Engineering.
• Provide technical leadership to a distributed R&D team.
• Develop innovative solutions to complex software system challenges.
• Contribute to system and software architectures for digital applications.
• Translate user needs into system requirements and lead cross-functional integration.
• Write and own system/software design inputs to meet QMS and regulatory standards.
• Lead ISO 14971 risk analysis activities and mitigation strategies.
• Define test strategies with verification engineers and perform ad-hoc testing.
• Interface with manufacturing, field service, operations, and customer training.

Skills

Agile execution

Systems engineering

Technical leadership

Requirements management

Risk analysis

Communication

Documentation in regulated industry

Education

Bachelor’s degree in engineering

Master’s degree

Job description

Your role at Baxter

Join our dynamic team as a Senior Principal 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

• 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 10+ years of experience , or a Master’s degree with 8+ 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 $144,000 to $198,000 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 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.

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.

• medical and dental coverage that start on day one
• insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
• Flexible Spending Accounts
• educational assistance programs
• 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
• commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• childcare benefits

Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.