Failure Analysis Engineer (Electrical & Mechanical) - Medical Devices

Our client is seeking an experienced Failure Analysis Engineer with a strong background in electrical and mechanical troubleshooting to investigate and resolve field installation failures and Out-of-Box Failures (OOBFs) for complex medical devices. This role focuses on identifying hardware-related failures through systematic root cause analysis and collaborating with cross-functional engineering teams to implement corrective actions. This is not a Quality Engineer position . The ideal candidate will possess hands‑on expertise in electrical hardware, mechanical assemblies, diagnostics, and failure investigation within regulated medical device or high‑tech manufacturing environments. Key Responsibilities Perform detailed failure analysis on medical devices returned from the field due to installation issues and Out-of-Box Failures (OOBFs). Investigate electrical, electromechanical, and mechanical hardware failures using structured engineering methodologies. Conduct root cause analysis (RCA) utilizing tools such as 5 Whys, Fishbone Diagrams, Fault Tree Analysis (FTA), and Design of Experiments (DOE). Troubleshoot complex electrical systems including PCBs, power supplies, wiring harnesses, sensors, motors, actuators, and embedded hardware. Diagnose mechanical failures involving assemblies, moving components, alignment issues, connectors, and structural components. Analyze field-returned units to determine failure mechanisms and document findings in comprehensive engineering reports. Collaborate with Design Engineering, Manufacturing Engineering, Product Development, Reliability Engineering, Service Engineering, and Supplier Quality teams to resolve product issues. Recommend corrective and preventive actions (CAPA) based on engineering findings to improve product reliability. Support design verification by validating corrective actions through testing and re-evaluation. Review engineering drawings, schematics, wiring diagrams, BOMs, assembly procedures, and manufacturing documentation. Utilize laboratory equipment including oscilloscopes, digital multimeters, logic analyzers, power analyzers, thermal cameras, and other diagnostic instruments. Execute functional, electrical, environmental, and mechanical testing to reproduce reported failures. Assist manufacturing teams with identifying recurring hardware issues and implementing process improvements. Document investigation results in compliance with FDA, ISO 13485, and internal engineering documentation standards. Support product reliability initiatives through trend analysis and failure data evaluation. Participate in engineering reviews to provide recommendations for product design improvements and increased field reliability. Required Qualifications Bachelor's degree in Electrical Engineering, Mechanical Engineering, Mechatronics Engineering, Biomedical Engineering , or a related engineering discipline. 5+ years of experience in failure analysis, hardware engineering, product support, reliability engineering, or sustaining engineering. Strong expertise in electrical and mechanical troubleshooting of complex hardware systems. Experience supporting medical devices, diagnostic equipment, imaging systems, laboratory instrumentation, or other electromechanical products. Proficiency in reading electrical schematics, PCB layouts, wiring diagrams, and mechanical drawings. Hands‑on experience with laboratory diagnostic equipment including oscilloscopes, digital multimeters, power supplies, and logic analyzers. Experience performing structured Root Cause Analysis (RCA) investigations. Strong documentation and technical reporting skills. Excellent analytical and problem‑solving abilities. Ability to work independently while collaborating effectively with cross‑functional engineering teams. Preferred Qualification sExperience supporting FDA-regulated medical device products

• Knowledge of ISO 13485, IEC 60601, and medical device regulatory requirements
• Familiarity with reliability engineering principles and failure modes analysis (FMEA)
• Experience with Design Verification (DV), Product Validation (PV), and sustaining engineering
• Exposure to manufacturing processes including PCB assembly, electromechanical integration, and final product testing
• Experience with statistical failure analysis and reliability metrics
• Familiarity with PLM, ERP, or engineering documentation management systems