Medical Device Design Quality Engineer (DHF Remediation)

Boston, MA

Job ID: 127423 Industry: Med

Medical Device Design Quality Engineer (DHF Remediation)

Environment: Our client is a large medical device manufacturer that develops a number of Class II & III Medical Devices. They are currently in need of a Design Quality Engineer to support a Design History File Remediation  and Risk File Remediation.

Responsibilities: This consultant will be responsible for legacy review and remediation of the client’ s Design History Files and Risk Files. The consultant should have experience performing Design History File and Risk gap analysis to discover findings, and remediating as necessary. They should have a thorough understanding of Risk Management and Product Requirements, Design Inputs, Design Outputs, Design V&V, DFMEA. The consultant should have a solid background with electromechanical medical devices. Must be comfortable being a point person for remediation activities.

Required:
  • Medical Device
  • DHF Remediation
  • Risk File Remediation
  • Electromechanical Device Experience

Job Type: Contract  

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