Senior Principal Software Systems Engineer; Assistance

Senior Principal Software Systems Engineer (Relocation Assistance), Baxter International Inc.

Join to apply for the Senior Principal Software Systems Engineer (Relocation Assistance) role at Baxter International Inc.

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.

• Driving Best Practices:
  Implement and champion best practices in software systems development and product life cycles, utilizing Agile PDLC/SDLC and Systems Engineering methodologies in collaboration with development and verification teams.
• 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.
• 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.
• Documentation 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.
• 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.

• 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.
• 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.
• Experience with cloud-based digital applications is preferred.
• Exceptional oral and written communication skills.
• Strong documentation skills and experience in a regulated industry.

Baxter…