Baxter International Inc.
Senior Principal Software Systems Engineer (Relocation Assistance)
Baxter International Inc., Raleigh, North Carolina, United States, 27601
Senior Principal Software Systems Engineer (Relocation Assistance)
Join Baxter International Inc. as a Senior Principal Software Systems Engineer and help transform healthcare technology. Your work will have a direct impact on patient lives and the mission to save and sustain lives.
Your Role at Baxter As a Senior Principal Software Systems Engineer in the R&D/Software organization, you will play a pivotal role in developing groundbreaking solutions for our Infusion Pump Platforms and connected Digital Applications group. You will be at the forefront of new product development and sustaining activities, ensuring we meet customer needs while adhering to the highest regulatory standards.
What You'll Be Doing
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.
Technical Leadership:
Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence.
Complex Problem Solving:
Deliver high‑quality technical solutions to complex software system challenges 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, and lead cross‑functional teams to integrate them.
Documentation and Compliance:
Write, maintain, and own system‑level and software‑level design inputs/requirements, ensuring compliance with 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, using requirement‑tracing methods.
Hands‑On Testing:
Conduct ad‑hoc testing of in‑development and developed software systems to ensure product quality.
Agile Execution:
Enforce and support teams in executing Agile/Scrum planning, including estimation, scheduling, and completing committed tasks.
Stakeholder Collaboration:
Drive collaboration with internal and external stakeholders to improve 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 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.
Compensation Estimated base salary: $128,000 – $176,000 annually. This range reflects anticipated salary and may vary based on market data and other factors. The position may also be eligible for discretionary bonuses.
Benefits (US) Baxter offers comprehensive health and well‑being benefits starting day 1, including medical, dental, life, accident, short‑term and long‑term disability, and business‑travel insurance. Financial benefits include the Employee Stock Purchase Plan (ESPP), 401(k) retirement savings plan with company matching, Flexible Spending Accounts, educational assistance, and generous paid time off. Additional benefits include commuting assistance, employee discount and assistance programs, family, and childcare support.
Equal Employment Opportunity Baxter is an equal‑opportunity employer. Applicants are evaluated without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity, protected veteran status, disability status, or any other legally protected characteristic.
Reasonable Accommodations We are committed to providing reasonable accommodations for individuals with disabilities worldwide. If you need an accommodation for any part of the application or interview process, please let us know by contacting us.
Recruitment Fraud Notice Beware of employment scams that impersonate Baxter employees or recruiters. Review our Recruitment Fraud Notice for guidance on protecting yourself.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Engineering and Information Technology
Industries Medical Equipment Manufacturing, Pharmaceutical Manufacturing, Hospitals and Health Care
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Your Role at Baxter As a Senior Principal Software Systems Engineer in the R&D/Software organization, you will play a pivotal role in developing groundbreaking solutions for our Infusion Pump Platforms and connected Digital Applications group. You will be at the forefront of new product development and sustaining activities, ensuring we meet customer needs while adhering to the highest regulatory standards.
What You'll Be Doing
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.
Technical Leadership:
Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence.
Complex Problem Solving:
Deliver high‑quality technical solutions to complex software system challenges 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, and lead cross‑functional teams to integrate them.
Documentation and Compliance:
Write, maintain, and own system‑level and software‑level design inputs/requirements, ensuring compliance with 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, using requirement‑tracing methods.
Hands‑On Testing:
Conduct ad‑hoc testing of in‑development and developed software systems to ensure product quality.
Agile Execution:
Enforce and support teams in executing Agile/Scrum planning, including estimation, scheduling, and completing committed tasks.
Stakeholder Collaboration:
Drive collaboration with internal and external stakeholders to improve 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 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.
Compensation Estimated base salary: $128,000 – $176,000 annually. This range reflects anticipated salary and may vary based on market data and other factors. The position may also be eligible for discretionary bonuses.
Benefits (US) Baxter offers comprehensive health and well‑being benefits starting day 1, including medical, dental, life, accident, short‑term and long‑term disability, and business‑travel insurance. Financial benefits include the Employee Stock Purchase Plan (ESPP), 401(k) retirement savings plan with company matching, Flexible Spending Accounts, educational assistance, and generous paid time off. Additional benefits include commuting assistance, employee discount and assistance programs, family, and childcare support.
Equal Employment Opportunity Baxter is an equal‑opportunity employer. Applicants are evaluated without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity, protected veteran status, disability status, or any other legally protected characteristic.
Reasonable Accommodations We are committed to providing reasonable accommodations for individuals with disabilities worldwide. If you need an accommodation for any part of the application or interview process, please let us know by contacting us.
Recruitment Fraud Notice Beware of employment scams that impersonate Baxter employees or recruiters. Review our Recruitment Fraud Notice for guidance on protecting yourself.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Engineering and Information Technology
Industries Medical Equipment Manufacturing, Pharmaceutical Manufacturing, Hospitals and Health Care
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