Medical Device Design Assurance SME

Boston, MA

Industry: Med Job Number: 122119

Medical Device Design Assurance/Design History File  SME


Our client is a leading supplier of medical devices. They are preparing to remediate their design history files and biocompatibility reports. They are in need of a Sr. Design Assurance subject matter expert to help with their risk documentation/work books. There will also be some work revolving around design FMEA.

Principle Duties and Responsibilities:

The consultant will be a Design Assurance/Design Quality Engineer from the medical device industry. The consultant must be comfortable hitting the ground running and rolling into a remediation effort atmosphere.The consultant will have an understanding of medical device regulations: ISO 13485, 21 CFR Part 820, ISO 14971. This consultant should have a long history of remediation efforts specifically with Design Assurance and design history files (DHF).

Required Skills:

· Design Assurance/Quality background

· Medical Device background

· ISO 13485, 21 CFR Part 820, ISO 14971

- Remediation Experience


· Instrumentation experience

Job Type: Contract 

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