DHF Remediation SME Consultant (Medical Device)

Denver, CO

Job ID: 125877 Industry: Med

Design History File Remediation SME (Medical Device)

Environment: Our client is a large medical device manufacturer. They are currently in need of a Design History File Subject Matter Expert to help remediate existing product DHF.

Responsibilities:
This consultant will be tasked with diving into existing product Design History Files to dictate whether or not they are efficient or need to be remediated. The consultant should have experience doing gap analysis of DHF structures to discover these findings and make proper recommendations and evaluations as to whether or not remediation is necessary. They should have a thorough understanding of Risk Management and Product Requirements and input and output verification matrices. They should be comfortable conducting and evaluating test reports and determining their efficiency as well. The consultant will work with a team of two or more other consultants with mechanical engineering backgrounds, but will act as a lead for the project. Must be comfortable being a point person for remediation activities.

Required:

Extensive Medical Device Experience
Design History File (DHF) Remediation 
Gap Analysis Experience

Plus:
Cardiac Devices

Job Type: Contract   

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