Failure Analysis Engineer

Role: Failure Analysis Engineer

Location: Newark, DE

Duration: 12 months

Note: Here client is not looking for a QE; they need someone from Electrical and Mechanical troubleshooting experience

Responsibilities:

· Investigate Out-of-Box Failures (OOBFs) and installation-related product failures reported from the field.

· Perform hands-on electrical and mechanical troubleshooting on returned medical device systems.

· Work in a Quality Engineering lab environment to replicate, analyze, and diagnose failure modes.

· Conduct root cause analysis (RCA) using structured engineering methods (e.g., 5 Whys, Fishbone, Fault Tree Analysis).

· Electrical schematics and wiring diagrams

· Mechanical drawings and assemblies

· Test data, logs, and system diagnostics

· Identify whether failures are related to:

· Electrical component or subsystem issues

· Mechanical design or assembly issues

· Manufacturing defects

· Supplier/component failures

· Installation or handling issues

· Document findings and clearly communicate technical conclusions.

· Partner with cross-functional teams including R&D, Manufacturing, Service, and Quality.

· Drive or support corrective and preventive acti CAPAs) to resolve and prevent recurrence of issues.

· Support ongoing remediation activities by completing timely and high-quality investigations.