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About the Role

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!

Responsibilities

Implement and champion best practices in software systems development and product lifecycles, utilizing Agile PDLC/SDLC and Systems Engineering methodologies.
Utilize AI (prompt engineering, agentic AI, AI extensions on existing tools, etc.) to implement rapid requirements and risk prototyping, while maintaining quality and accuracy.
Provide guidance, mentorship, and technical leadership to a distributed R&D team.
Develop innovative technical solutions to complex software system challenges.
Assist in establishing robust system and software architectures for digital applications.
Ensure systems of systems and interoperability considerations are accounted for and represented in the architectures.
Identify and capture user needs for digital applications, translating them into functional and non-functional system requirements.
Lead cross-functional teams to ensure user needs are effectively integrated into system requirements.
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.
Lead ISO 14971-based risk analysis activities.
Collaborate with verification engineers to define test strategies for system and software verification and validation plans.
Conduct ad-hoc testing of in-development and developed software systems.
Enforce and support teams in executing Agile/Scrum planning, including estimating, scheduling, and completing committed tasks.
Drive collaboration with internal and external stakeholders to enhance processes, practices, and technical mentorship.
Interface with manufacturing, field service, operations, and customer training staff throughout the design transfer process.
Ensure that product complaints and issues are addressed promptly, with appropriate impact assessments on requirements and risks.
Uphold compliance with the product development process and quality system standards.

Requirements

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.
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.
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.
Applicants must be authorized to work for any employer in the U.S.
Unable to sponsor or take over sponsorship of an employment visa at this time.

Skills

Agile PDLC/SDLC
Systems Engineering methodologies
AI (prompt engineering, agentic AI, AI extensions on existing tools, etc.)
Requirements management
Risk management
Agile environment
Product backlogs
Medical device cybersecurity design paradigms
Oral communication
Written communication
Documentation
Cloud-based digital applications
AWS/Azure or similar CSPs
AI/ML paradigms

Location

Work Type

Flexible workplace policy with a required minimum number of days a week onsite

Experience Level

3+ years of experience
Senior

Education Level

Bachelor’s degree in an engineering discipline

Salary/Compensations

$104,000 to $143,000 annually

Benefits

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)
401(k) Retirement Savings Plan (RSP)
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 (EAP)
Childcare benefits

About the Company

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life.
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.

Equal 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.
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