System Integration Engineer – Medical Device Systems

System Integration Engineer – Medical Device Systems

Location: Palo Alto, CA

Experience: 10+ years

Education: Bachelor’s or Master’s degree in electrical engineering, Electronics Engineering, Systems Engineering, or a related discipline.

Key Responsibilities

• Define system level interface specifications & drive system integration plan.
• Integrate hardware, software, firmware, controls, imaging and electromechanical subsystems into complete medical-device systems during development phase.
• Plan and execute system integration, verification and validation activities to ensure product performance, reliability and safety.
• Perform hands-on integration, prototype bring-up, debugging and troubleshooting of complex electromechanical systems.
• Investigate system-level issues and perform root-cause analysis using logs, diagnostic tools and engineering data.
• Troubleshoot interoperability, timing, communication and interface-related defects across multiple subsystems.
• Collaborate with Systems, Electrical, Software, Mechanical, Quality and Manufacturing Engineering teams to resolve technical challenges.
• Collaborate with Verification & Validation team in developing and executing integration test plans, test procedures and verification protocols.
• Independently drive defect investigation, resolution and corrective actions through cross-functional collaboration.
• Participate in design reviews, integration readiness reviews, risk assessments and FMEA activities.
• Document test results, issue investigations, verification evidence and engineering recommendations.
• Support design-control documentation and system verification evidence in regulated medical-device environments.
• Identify opportunities to improve integration processes, test automation and engineering efficiency.

Required Qualifications

• 10+ years of experience in system integration, verification, validation, product development or sustaining engineering.
• Strong understanding of complex electromechanical systems, embedded systems and hardware-software interactions.
• Hands-on experience debugging hardware, firmware, software, controls and communication interfaces.
• Experience developing test plans and troubleshooting multidisciplinary engineering systems.
• Working knowledge of system-level testing methodologies and defect management processes.
• Strong analytical and problem-solving skills, with the ability to independently investigate and resolve complex technical issues.
• Excellent technical documentation, communication and cross-functional collaboration skills.

Preferred Qualifications

• Experience with medical-device product development, design controls and verification documentation.
• Familiarity with ISO 13485, ISO 14971 and IEC 60601 or equivalent regulated product standards.
• Experience with radiation therapy equipment, imaging systems, medical instrumentation or other complex safety-critical electromechanical products.
• Experience with test automation, diagnostic tools and system integration laboratories.