Design Assurance Engineer (Software)

Boston, MA

Industry: Medical Device Job Number: 134676

 

Design Assurance Engineer

Background:

Our client is a global manufacturer of Class II and III Medical Devices. They are currently in need of a Design Assurance Engineer to support a Software Update.

Duties/Responsibilities:

This individual will be joining a software update project for an existing device. This individual will be responsible for working on design verifications, execution of documentation, DHF Support, Trace Matrix and will we working with other design/risk engineers for a software update project for an existing device. The consultant will be working with documentations such as risk management plans and reports, DHF, Design V&V, and making sure documentation is up to ISO 14971 and 13485 standards. Must have experience working with Software products.

This person will NOT need experience coding or debugging but they must be able to do defect tracking when necessary.

Required:
  • Software Assurance/Software Quality Experience
  • Medical Device
  • Knowledge/Exposure to DHF
  • ISO 14971
  • IEC 62304

Preferred:
  • Windchill

Job Type: Contract

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