Principal Systems Engineer (Medical Devices) -

Principal Systems Engineer (Medical Devices)Location: Bellevue, WA Work Arrangement: Hybrid (Flexible onsite and remote schedule) Duration: 12-Month ContractPay: $60/hr. on c2c Work Schedule: Typically 8:00 AM – 5:00 PM (hours may vary)Job SummaryWe are seeking an experienced Principal Systems Engineer to join an innovative R&D team developing next-generation connected medical device solutions in the cardiology space. This role is responsible for leading the development, integration, verification, and validation of complex end-to-end systems involving wearable medical devices, mobile applications, cloud platforms, software algorithms, and data pipelines.The ideal candidate will have strong systems engineering expertise, experience working in regulated medical device environments, and the ability to collaborate across multiple engineering disciplines.Key ResponsibilitiesLead system integration planning and testing across wearable devices, mobile applications, software algorithms, cloud platforms, and user portals.Develop and execute comprehensive verification and validation (V&V) plans, test protocols, and test reports.Create system models, perform risk analyses, and develop mitigation strategies for complex integrated systems.Collaborate with hardware, software, and data engineering teams to evaluate system performance, reliability, and data integrity throughout the product lifecycle.Apply systems engineering principles and best practices throughout product development.Support system-level verification, validation, and troubleshooting activities.Analyze and resolve hardware and software integration issues.Ensure compliance with medical device regulations, quality standards, and data privacy requirements.Provide technical leadership and systems engineering guidance to cross-functional project teams.Drive projects to successful completion through collaboration and technical leadership.Required QualificationsBachelor's or Master's degree in Electrical Engineering, Biomedical Engineering, Computer Engineering, Systems Engineering, or a related engineering/science discipline.5–8+ years of systems engineering experience with a strong emphasis on connected medical devices or other complex hardware/software integrated systems.Experience leading development of end-to-end systems involving embedded hardware, sensors, mobile applications, cloud platforms, and software algorithms.Strong knowledge of: Systems Modeling, Requirements Management, Risk Analysis, Design Verification & Validation, Functional Testing.Experience developing verification and validation plans and functional test procedures.Understanding of medical device regulations, quality systems, and data privacy requirements.Intermediate knowledge of electro-mechanical hardware qualification and statistics.Experience with Python scripting and RESTful APIs.Strong debugging and troubleshooting skills across hardware and software.Excellent analytical, organizational, communication, and problem-solving skills.Ability to work effectively within cross-functional engineering teams.Preferred QualificationsExperience with CAD tools.Familiarity with Azure DevOps (ADO) or similar CI/CD platforms.Experience with design control, version control, and requirements management tools.Experience working in regulated medical device product development.Preferred SkillsSystems EngineeringConnected Medical DevicesWearable DevicesHardware & Software IntegrationVerification & Validation (V&V)Requirements ManagementRisk AnalysisEmbedded SystemsSensorsMobile ApplicationsCloud TechnologiesPythonREST APIsAzure DevOpsElectro-Mechanical SystemsDebugging & TroubleshootingTest PlanningData EngineeringProduct DevelopmentCross-Functional Leadership