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.

• 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.

• 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.

• 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