Systems Engineer

Role:
Systems Engineer

Location:

Pleasanton, CA

Contract Duration: 12 Months

We are seeking an experienced Systems Engineer to lead system integration activities for complex, regulated medical devices. This role will support both new product development and sustaining engineering initiatives, focusing on the integration of mechanical, electrical, embedded software, mobile applications, wireless technologies, and cloud-connected systems. The ideal candidate will bring strong systems engineering expertise, hands-on integration experience, and the ability to work independently while collaborating with cross-functional teams in a fast-paced medical device environment.

• Lead system integration planning and execution throughout the product lifecycle, from architecture and design through verification, validation, and design transfer.
• Define and manage system integration strategies, interface requirements, integration sequencing, and risk mitigation plans.
• Coordinate integration activities across hardware, embedded software, mobile applications, wireless communication technologies, and cloud-based platforms.
• Support system architecture development, interface management, and requirements allocation across multidisciplinary teams.
• Partner with Systems, Software, Hardware, Quality, Clinical, and Regulatory teams to identify and resolve integration issues through structured root-cause analysis.
• Support system-level verification and validation activities, ensuring traceability, test readiness, and issue resolution.
• Lead technical reviews, communicate integration risks and trade-offs, and provide technical guidance to project teams.
• Ensure compliance with quality systems, design controls, configuration management, and change management processes.
• Collaborate with global engineering teams, vendors, and stakeholders to achieve project objectives and deliverables.

• Bachelor's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Software Engineering, Computer Science, or a related technical discipline with 5-6 years of relevant experience; OR
• Master’s degree in a related field with 4+ years of relevant experience.
• Proven experience leading system integration activities involving both hardware and software components.
• Strong understanding of system architecture, interface management, and complex system behavior.
• Experience working in regulated product development environments (medical devices preferred).
• Hands-on experience collaborating across software, hardware, and systems engineering teams.
• Knowledge of design controls, configuration management, defect tracking, and change control processes.
• Excellent communication, technical documentation, and stakeholder management skills.
• Ability to work independently and drive projects in a matrixed organization.