Sr. Software Systems Engineer
About The Position
Baxter is hiring a Senior Software Systems Engineer in its R&D/Software organization to support new product development and sustaining activities for Infusion Pump Platforms and the connected ecosystem Digital Applications group. The role contributes to healthcare solutions while ensuring customer needs are met and regulatory standards are followed. The engineer will guide software systems development across the product lifecycle, contribute to digital-application architectures, and lead requirements, risk-management, and verification planning activities. The role also provides technical leadership to a distributed R&D team, supports Agile execution, conducts hands-on testing, and works with internal and external stakeholders across development, manufacturing, field service, operations, and customer training. The position follows Baxter’s flexible workplace policy, which requires a minimum number of onsite days per week; the specific number is not stated.
Requirements
- Bachelor’s degree in an engineering discipline.
- At least 3 years of experience.
- Proven experience with regulated products and connected systems in the medical devices or biotechnology industry.
- Expertise in requirements management, risk management, and development in an Agile environment, including creating and maintaining product backlogs.
- Exceptional oral and written communication skills.
- Strong documentation skills and experience in a regulated industry.
Nice To Haves
- Experience with cloud-based digital applications, such as SaaS/PaaS/IaaS environments using AWS, Azure, or similar cloud service providers.
- Experience implementing AI/ML paradigms in digital applications.
- Familiarity with electro-mechanical devices.
- Knowledge of implementing and enforcing medical device cybersecurity design paradigms.
Responsibilities
- Implement and champion software systems development and product lifecycle best practices, using Agile PDLC/SDLC and Systems Engineering methods with development and verification teams.
- Use AI approaches, including prompt engineering, agentic AI, and AI extensions to existing tools, for rapid requirements and risk prototyping while maintaining quality and accuracy.
- Provide guidance, mentorship, and technical leadership to a distributed R&D team.
- Develop technical solutions to complex software system challenges and deliver results within tight deadlines.
- Assist in establishing system and software architectures for digital applications, aligned with design inputs and accounting for systems-of-systems and interoperability considerations.
- Identify and capture user needs for digital applications, translate them into functional and non-functional system requirements, and lead cross-functional integration of those needs.
- Write, maintain, and own system-level and software-level design inputs and requirements in compliance with QMS and regulatory frameworks including ISO 13485 and IEC 62304.
- Lead ISO 14971-based risk analysis, identifying inherent hazards and implementing mitigation strategies.
- Collaborate with verification engineers to define test strategies for system and software verification and validation plans using requirements tracing.
- Conduct ad-hoc testing of in-development and developed software systems.
- Support and enforce Agile/Scrum planning, including estimating, scheduling, and completing committed tasks.
- Drive collaboration with internal and external stakeholders to improve processes, practices, and technical mentorship, and translate software requirements into effective test architectures.
- Interface with manufacturing, field service, operations, and customer training staff during design transfer.
- Ensure product complaints and issues are addressed promptly, including impact assessments on requirements and risks.
- Uphold compliance with the product development process and quality system standards.
Benefits
- Medical and dental coverage starting on day one for eligible roles.
- 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 with employee contributions and company matching.
- Flexible Spending Accounts.
- Educational assistance programs.
- Paid holidays and 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.
- The position may be eligible for discretionary bonuses.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
