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SYSTEMS ENGINEER – INTEGRATION

TekHawks · Pleasanton, CA

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SYSTEMS ENGINEER – INTEGRATIONLocation: Pleasanton, CADuration: 1 year, possible extensionsOverviewSeeking a senior-level Systems Engineer to lead system-level integration for complex, regulated medical devices. The engineer will coordinate the integration of hardware, embedded software, mechanical components, mobile applications, wireless technologies, and cloud-connected services across new product development and sustaining programs.ResponsibilitiesLead system integration planning and execution across the full product lifecycle.Define the integration strategy, sequencing, interface definitions, and mitigation of integration risks.Support system architecture, integration requirements, and interface control across hardware and software domains.Coordinate end-to-end integration across embedded firmware, mechanical, mobile, wireless, and cloud components.Ensure requirements are clear, allocatable, and integrable across engineering disciplines.Identify integration issues early and drive them through root-cause analysis and resolution.Ensure integrated systems are traceable, test-ready, and prepared for formal verification and validation.Communicate technical risks, tradeoffs, system impacts, and project status to cross-functional teams and leadership.Support design transfer, sustaining activities, and applicable quality-system requirements.Target BackgroundBachelor’s degree with approximately 5–6 years of relevant experience, or a master’s degree with at least 4 years of relevant experience.Demonstrated experience leading system integration for complex products involving both hardware and software.Strong understanding of system architecture, interface control, integration sequencing, and multi-component system behavior.Hands-on experience working across Systems, Software, Hardware, and Test Engineering.Experience in regulated product development; medical device experience is strongly preferred, although aerospace, automotive, or similar industries may be considered.Working knowledge of design controls, configuration management, defect tracking, and change-management processes.Experience supporting Class II/III medical device submissions is highly desirable.Experience with DOORS, JIRA, or similar requirements and defect-management tools.Familiarity with IEC 62304, IEC 60601, ISO 14971, or comparable standards is preferred.Experience integrating mobile applications, Bluetooth, Wi-Fi, cloud services, embedded firmware, and automated electromechanical system tests is preferred