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Baxter is seeking a Principal Systems Engineer for its R&D team at the Bellevue office. The role involves developing and integrating complex medical device systems such as wearables, mobile apps, software algorithms, cloud apps, user portals, gateways, and data pipelines. Key focus areas include hardware and software integration, risk analysis, requirements management, and system performance evaluation.
Job Responsibility:
Lead the definition and capture of system architecture, requirements, and specifications for end-to-end medical device systems, ensuring seamless integration and interoperability between wearable devices, mobile applications, software algorithms, cloud software applications, and user portals
Define, document, and manage system requirements across all components of the end-to-end system, ensuring traceability and alignment with regulatory standards
Ensure comprehensive test plans and protocols to verify and validate system performance, safety, and security across the entire end-to-end ecosystem
Evaluate system integration points and lead the team in integration planning and testing
Develop comprehensive system models, risk analyses, and mitigation strategies, addressing the unique challenges of each component in the end-to-end system
Work with development engineers to analyze system performance, reliability, and data integrity across the entire data pipeline, from wearable device data collection to cloud storage and processing
Lead project teams in adhering to systems engineering standards during the Baxter Product Development process.
Requirements:
Bachelor's degree in Systems Engineering, Biomedical Engineering, Computer Engineering, or a related field
5+ years of experience in systems engineering, with a significant focus on connected medical devices or other complex, end-to-end systems involving hardware and software integration
Leadership in developing end-to-end systems, preferably in medical device or healthcare industry
Expertise in systems modeling, requirements management, risk analysis, verification, and validation
Strong understanding of medical device regulations, quality systems, and data privacy regulations
Broad technical knowledge in hardware, software, and data engineering
Experience in requirements definition, flow-down, management, validation, and verification practices
Strong ability to build consensus, drive complex systems, and communicate effectively in diverse, multi-functional teams
Applicants must be authorized to work for any employer in the U.S.
What we offer:
Support for Parents
Continuing Education/ Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage starting 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)
401(k) Retirement Savings Plan with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits including paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
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