Baxter International Inc. · 1 month ago
Senior Principal Software Systems Engineer (Relocation Assistance)
Raleigh, North Carolina
Full-time
Onsite
Senior Level, Lead/Staff
$128K/yr - $176K/yr
8+ years expBaxter International Inc. is dedicated to redefining healthcare delivery and is seeking a Senior Principal Software Systems Engineer to join their R&D/Software organization. This role involves developing innovative healthcare solutions, leading technical teams, and ensuring compliance with regulatory standards in product development.
BiotechnologyClinical TrialsHealth CareMedical
Responsibilities
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
Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence
Develop innovative technical solutions to complex software system challenges, delivering high-quality results within tight deadlines
Assist in establishing robust system and software architectures for digital applications, ensuring alignment with established design inputs
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
Write, maintain, and own system-level and software-level design inputs/requirements, ensuring compliance with established Quality Management Systems (QMS) and regulatory frameworks
Lead ISO 14971-based risk analysis activities, from identifying inherent hazards to implementing effective mitigation strategies
Collaborate with verification engineers to define test strategies for system and software verification and validation plans, utilizing requirement tracing methods
Conduct ad-hoc testing of in-development and developed software systems to ensure ongoing product quality
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, transforming software requirements into effective test architectures
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
Qualification
Required
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
Expertise in requirements management, risk management, and development in an Agile environment, including experience in creating and maintaining product backlogs
Exceptional oral and written communication skills
Strong documentation skills and experience in a regulated industry
Preferred
Familiarity with electro-mechanical devices
Knowledge of implementing and enforcing medical device cybersecurity design paradigms
Experience with cloud-based digital applications
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), 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
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
Company
Baxter International Inc.
For nearly a century, we have delivered on our commitment to saving and sustaining the lives of patients, working alongside clinicians and providers around the world.
10001+ employees
H1B Sponsorship
Baxter International Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (15)
2024 (10)
2023 (17)
2022 (18)
2021 (6)
2020 (14)
Funding
Current Stage
Public CompanyTotal Funding
$2.28BKey Investors
German Federal Ministry of Education and Research
2025-12-08Post Ipo Debt· $600M
2021-04-21Grant· $1.81M
2019-05-15Post Ipo Debt· $1.68B
Leadership Team
Andrew Hider
President and Chief Executive Officer
Giuseppe Accogli
EVP & Chief Operating Officer
Recent News
HospitalManagement.net
2026-01-16
Company data provided by crunchbase