Senior Failure Analysis Technician

Location: Irvine, CA (on-site)

EPM is partnering with a growing medical device company in Orange County looking to bring on a Senior Failure Analysis Technician to support complex product investigations within a Class II environment. This is a highly technical, hands‑on role where you'll act as a subject matter expert for failure analysis across endovascular devices.

Key Responsibilities:

• Lead complex failure investigations across customer complaints, returned products, and manufacturing issues
• Perform detailed product analysis (visual, functional, dimensional) to identify failure modes and root causes
• Review DHRs, test data, and manufacturing records to support thorough investigations and conclusions
• Partner with Engineering, Quality, and Regulatory to drive CAPA and corrective actions based on findings
• Analyze trends in failure data and provide technical reports suitable for regulatory and internal review

Qualifications:

• Associate's or Bachelor's in Engineering, Life Sciences, or related field
• 7+ years in failure analysis, complaint handling, and root cause investigations in med device
• Strong experience with Class II/III endovascular products and returned product analysis
• Hands‑on knowledge of FDA regulations, ISO 13485, CAPA, and nonconformance processes
• Proficiency with RCA tools (5 Whys, Fishbone, Fault Tree) and interpreting DHRs/test data