WHAT YOU'LL DO

The Systems Engineer is a senior-level individual contributor responsible for leading and executing system-level verification activities for complex, regulated medical devices. This role focuses on ensuring that system requirements are well-defined, traceable, testable, and objectively verified across hardware, software, mobile applications, wireless technologies, and cloud-connected services. Based in Pleasanton, CA, the engineer is accountable for developing verification strategies, defining test methodologies, planning and executing system verification activities, and ensuring that products meet intended use, performance requirements, quality standards, and regulatory expectations. The role requires strong technical depth in systems engineering, verification methodologies, and root-cause analysis. The engineer will collaborate closely with Systems, Software, Hardware, Quality, Clinical, Regulatory, and Test Engineering teams to ensure comprehensive verification coverage and timely resolution of system-level issues throughout the product lifecycle.

RESPONSIBILITIES

Lead system verification planning and execution across the full product lifecycle, from requirements development through design transfer and sustaining activities. Develop and maintain system verification strategies, verification plans, protocols, reports, and traceability matrices. Analyze system requirements for completeness, consistency, and testability, ensuring clear verification methods are defined. Define system-level test approaches, acceptance criteria, and verification coverage for complex hardware-software systems. Establish and maintain bidirectional traceability between stakeholder needs, system requirements, risk controls, and verification evidence. Design, develop, and execute system-level verification protocols to confirm compliance with functional, performance, safety, and reliability requirements. Lead system defect investigation, root-cause analysis, and verification of corrective actions. Support risk management activities by ensuring design mitigations are appropriately verified and documented. Collaborate with cross-functional engineering teams to identify verification gaps, resolve technical issues, and improve product quality. Review design changes and assess verification impacts throughout product development and sustaining efforts. Support verification readiness reviews, design reviews, regulatory submissions, and audit activities. Drive continuous improvement of verification processes, methodologies, tools, and best practices. Communicate verification status, risks, technical findings, and recommendations to project teams and leadership Cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

EDUCATION AND EXPERIENCE YOU'LL BRING

Required Bachelor's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Software Engineering, Computer Science, or related technical field with 5-6 years of relevant experience, OR Master's degree in a related technical field with a minimum of 4 years of relevant experience. Demonstrated experience leading system-level verification efforts for complex hardware-software products. Strong understanding of requirements engineering, requirements traceability, and verification methodologies. Experience developing verification plans, protocols, test methods, and verification reports. Experience working in regulated product development environments (medical devices preferred; aerospace, automotive, defense, or similar industries acceptable). Strong knowledge of system test design, defect management, root-cause analysis, and issue resolution. Experience supporting risk management activities and verification of risk control measures. Familiarity with design controls, configuration management, change management, and quality system processes. Excellent written and verbal communication skills with the ability to communicate complex technical information to diverse stakeholders. Proven ability to independently drive verification activities in cross-functional environments. Experience supporting regulatory submissions for Class II and/or Class III medical devices. Preferred Medical 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 similar Experience developing automated system-level verification solutions and test frameworks. Experience verifying systems involving embedded firmware, mobile applications, Bluetooth, Wi-Fi, cloud services, and cybersecurity features. Experience working with requirements, configuration, and defect management tools (e.g., DOORS, JIRA, etc.) Experience supporting verification activities through validation, design transfer, and post-market sustaining efforts. Strong systems-thinking mindset with the ability to balance technical depth and big-picture impacts Strong organizational skills, ability to prioritize work, and consistent attention to detail

Pay:

$110,000.00 - $120,000.00 per year

Benefits:

401(k) Health insurance Paid time off Professional development assistance

Work Location:

In person