Sr. Software Systems Engineer

Posted 4 Hours Ago
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Raleigh, NC, USA
In-Office
104K-143K Annually
Senior level
Healthtech • Other
The Role
Leads software systems engineering for regulated medical-device digital applications and infusion-pump platforms. Responsibilities include architecture, user-needs translation, requirements and risk management, verification and validation planning, Agile execution, hands-on testing, regulatory compliance, design transfer, stakeholder collaboration, and technical mentorship. The role applies standards including ISO 13485, IEC 62304, and ISO 14971, while supporting cloud-based applications and emerging AI capabilities.
Summary Generated by Built In

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.

#LI-OM1

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. 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.

Skills Required

  • Bachelor’s degree in an engineering discipline
  • 3+ years of professional experience
  • Experience with regulated products and connected systems in the medical device or biotechnology industry
  • Experience with requirements management, risk management, Agile development, and product backlog maintenance
  • Exceptional oral and written communication skills
  • Strong documentation skills and experience in a regulated industry
  • Experience with cloud-based digital applications, including SaaS, PaaS, IaaS, AWS, Azure, or similar cloud service providers
  • Experience implementing AI/ML paradigms in digital applications
  • Familiarity with electromechanical devices
  • Knowledge of medical-device cybersecurity design practices

Baxter International Inc. Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Baxter International Inc. and has not been reviewed or approved by Baxter International Inc..

  • Healthcare Strength — Health coverage begins on day one and includes medical, dental, and company-paid life and disability, indicating robust protection. This breadth of coverage is positioned as a strong component of the total rewards package.
  • Retirement Support — A 401(k) with company match and related retirement programs support long-term savings. An additional savings infrastructure enhances overall financial security for many roles.
  • Leave & Time Off Breadth — PTO scales with tenure and is complemented by paid holidays and meaningful paid parental leave. The scope of time-off programs contributes to a well-rounded benefits offering.

Baxter International Inc. Insights

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The Company
HQ: Deerfield, IL
35,858 Employees
Year Founded: 1931

What We Do

Every day, millions of patients, caregivers and providers around the world rely on Baxter’s leading portfolio of diagnostic, critical care, nutrition, kidney care, hospital and surgical products and solutions. For 90 years, we’ve been making an impact at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, therapies and digital health solutions available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. We welcome Hillrom to Baxter, where we are uniting to advance patient care worldwide. We’re building on the strengths of two historically innovative and socially responsible companies that will better serve our patients, customers and communities.

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