Medical Device Design Risk Management Engineer

Syracuse, NY

Job ID: 125363 Industry: Med

 

Medical Device Design Risk Management Engineer

Background:

Our client is a large Medical Device organization. They develop and manufacture a number of Class II & Class III Endoscopic Medical Devices. They are currently in need of a Design Risk Management Engineer to provide support for a remediation effort.

Scope of Work:

Our client seeks a hands-on candidate well-versed in Design Risk Management (DFMEA), Design Verification and Validation (Design V&V), and Design History File (DHF) Remediation.  This individual will work under the R&D team, and will be focused on gap analysis and remediation of Design documentation such as DHF, Design Control documents, and Design V&V protocols/procedures. This candidate should have a background in both the remediation strategy (DHF Gap Analysis/Design Risk Assessments), but more importantly with the hands-on technical writing and execution of Design V&V Protocols, DFMEA’ s, etc.

The consultant should be highly proficient in 21 CFR Part 820,  Design V&V, and should have experience working in a DHF Remediation project.

Required Experience:
  • Medical Device
  • Design Risk Management
  • Design History File Remediation (DHF)
  • Writing DFMEA’ s
  • Writing & Executing Design V&V Protocols
  • BS in Mechanical Engineering (or equivalent)
  • Technical R&D/NPD/Design Engineering Experience

Job Type: Contract  

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