Position Details
About this role
This role involves conducting failure investigations on FDA-approved medical devices, leading CAPAs, and improving product reliability in a healthcare setting.
Key Responsibilities
- Investigate device malfunctions
- Develop failure analysis techniques
- Lead CAPAs
- Analyze failure data
- Coordinate design changes
Technical Overview
The technical environment includes failure analysis techniques, root cause analysis, test fixture design, and statistical tools, with a focus on medical device troubleshooting and compliance.
Ideal Candidate
The ideal candidate is a mid-level engineer with 2+ years of experience in failure analysis within the medical device industry, possessing strong root cause analysis and project management skills, and familiar with FDA regulations.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of related scientific discipline degree, Less than 2 years of relevant experience, No experience with failure analysis or root cause analysis, Unfamiliar with FDA regulations
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