Job Category: Research & Development / Systems Engineering / Medical Devices
Reference ID: JR-187732
Location: Raleigh, North Carolina, United States
Company: Baxter International Inc.
Employment Type: Full-Time
Work Authorization: U.S. work authorization required (no visa sponsorship available)
About the Company
Baxter International Inc. is a global healthcare organization dedicated to advancing patient care through innovative medical devices, pharmaceuticals, and digital health technologies. Operating in more than 100 countries, Baxter’s mission to save and sustain lives drives continuous innovation across its Research & Development (R&D) ecosystem.
The company fosters a collaborative, cross-functional engineering environment where systems thinking, regulatory rigor, and technical excellence converge to develop life-saving healthcare solutions.
Position Overview
The Principal Systems Engineer, R&D will play a strategic leadership role in defining system requirements, managing technical risks, and guiding the development of complex medical device systems integrating hardware, embedded software, network communications, and web services.
This role is critical in translating customer needs, regulatory requirements, and business constraints into structured system-level specifications. The successful candidate will ensure robust system architecture, risk mitigation, and compliance throughout the product development lifecycle.
This opportunity is ideal for experienced systems engineers with strong analytical skills, regulatory awareness, and cross-functional leadership experience in regulated healthcare environments.
Key Responsibilities
Systems Requirements & Architecture
Engage with internal stakeholders, business partners, and customers to gather and analyze technical requirements.
Translate user needs and regulatory constraints into detailed functional and performance requirements.
Collaborate with system architects and engineering teams to define system modules, interfaces, operating environments, and interdependencies.
Develop and maintain concise yet comprehensive functional specification documentation.
Risk Management & Compliance
Lead risk management activities in alignment with medical device development standards.
Maintain and update risk management plans, hazard analyses, and mitigation strategies.
Conduct Design Failure Mode and Effects Analysis (DFMEA) and structured Risk/Hazard Analysis.
Ensure system interfaces are secure, reliable, and compliant with regulatory expectations.
Cross-Functional Leadership
Facilitate technical discussions, requirements reviews, and stakeholder alignment sessions.
Support conflict resolution and drive consensus across engineering, quality, regulatory, and business teams.
Make timely, high-quality decisions in ambiguous or evolving project environments.
Influence without direct authority and mentor junior engineers when required.
Required Experience & Qualifications
Education
Bachelor’s Degree in Computer Science, Computer Engineering, Electrical Engineering, Industrial Engineering, or related technical discipline
Equivalent combination of education and professional experience may be considered
Professional Experience
Minimum 5+ years of experience in one or more of the following roles:
Systems Engineer
Business Analyst (technical environment)
Systems Analyst
Requirements Engineer
Experience working on complex integrated hardware and software systems
Proven involvement in embedded systems, network communications, and web-based service architectures
Experience within regulated industries such as medical devices, healthcare technology, or life sciences preferred
Technical & Professional Skills
Strong expertise in requirements elicitation and system specification development
Hands-on experience with risk management methodologies including DFMEA
Excellent written and verbal communication skills
Ability to lead technical meetings and deliver executive-level presentations
Strategic thinker with strong analytical and detail-oriented execution capabilities
Comfortable working in dynamic environments with incomplete information
Compensation & Benefits
Estimated Base Salary: USD $104,000 – $143,000 annually (based on experience, skills, and location)
Potential eligibility for discretionary performance bonuses
Comprehensive health, dental, and insurance coverage starting day one
401(k) with company matching
Employee Stock Purchase Plan (ESPP)
Paid time off (20–35 days based on tenure)
Paid parental leave and family support programs
Educational assistance and professional development programs
Flexible workplace policy with minimum onsite requirements
Equal Employment Opportunity
Baxter International Inc. is an Equal Opportunity Employer. All qualified applicants will be considered without regard to race, religion, gender, national origin, age, disability, veteran status, sexual orientation, or other legally protected characteristics.
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