Senior Failure Analysis Technician
Role: Senior Failure Analysis Technician
Salary: $85k - $95k
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
Benefits:
- Competitive compensation
- Bonus
- Medical, vision, dental
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