Systems Engineer

Job title: Systems EngineerLocation: Pleasanton CA 94588Duaration: 12 MonthsThe Systems Engineer is a senior-level individual contributor responsible for leading and executing system-level integration activities for complex, regulated medical devices. This role focuses on delivering systems engineering efforts across sustaining and new product development programs, including the integration of hardware, embedded software, mobile applications, wireless technologies, and cloud-connected services.Based in Pleasanton, CA, the engineer is accountable for ensuring that all system elements are effectively integrated, interfaces are clearly defined and verified, and overall system performance meets intended use, quality standards, and regulatory requirements. The role requires strong technical depth, systems thinking, and the ability to operate with minimal supervision while independently leading integration efforts. The engineer collaborates closely with cross-functional teams - including Systems, Software, Hardware, Quality, Clinical, and Regulatory - and coordinates with global engineering personnel to ensure alignment, resolve interdependencies, and drive successful project completion.ResponsibilitiesLead system integration planning and execution across the full product lifecycle, from early architecture through verification, design transfer, and sustaining activitiesDefine and manage the system integration strategy, including integration sequencing, interface definition, and mitigation of integration risksSupport and maintain system architecture, interface definitions, and integration requirements across hardware and software domainsCoordinate end-to-end integration activities across embedded firmware, mechanical components, mobile applications, and cloud-connected servicesPartner with Systems, Software, and Hardware Engineering to ensure requirements are clear, allocatable, integrable, and that integration issues are identified early and resolved through root-cause analysisSupport system-level verification and validation by ensuring integrated systems are test-ready, traceable, and issues are resolved prior to formal testingCommunicate integration risks, technical tradeoffs, and system impacts, lead technical reviews, provide mentorship, and ensure compliance with applicable quality system requirementsCommunicate effectively with cross-functional teams and senior management. Keeps leadership informed of progress and issues.Cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.RequiredEducation And Experience You ll Bring Bachelor s degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Software Engineering, Computer Science, or a related technical field with 5-6 years of relevant experience, ORMaster s degree in a related technical field with a minimum of 4 years of relevant experienceDemonstrated experience leading system integration for complex products involving both hardware and softwareStrong understanding of system architecture, interface control, and multi-component system behaviorExperience working in regulated product development environments (medical devices strongly preferred; aerospace, automotive, or similar also acceptable)Hands-on experience collaborating across hardware, software, and systems disciplinesWorking knowledge of design control, configuration management, defect tracking, and change management processesExcellent written and verbal communication skills, with the ability to clearly communicate complex technical concepts to cross-functional stakeholdersProven ability to work independently, prioritize effectively, and drive results in a matrixed organizationExperience supporting regulatory submissions for Class II/III medical devicesPreferredMedical device experience, particularly with connected or software-enabled medical devices.Familiarity with relevant standards such as IEC 62304 (Software Lifecycle), IEC 60601, ISO 14971, or similarExperience integrating systems involving mobile applications, wireless technologies (e.g., Bluetooth, Wi Fi), and cloud-based servicesExperience working with requirements, configuration, and defect management tools (e.g., DOORS, JIRA, etc.)Experience supporting system integration through verification, validation, and design transferStrong systems-thinking mindset with the ability to balance technical depth and big-picture impactsStrong organizational skills, ability to prioritize work, and consistent attention to detailExperience developing or supporting automated system-level tests involving integrated mechanical, electrical, and software components