Medical Device Development Engineer

Fort wayne, IN

Industry: Medical Device Job Number: 134806

  Medical Device Development Engineer

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 New Product Development Quality Engineer to support a new product launch from a Quality Engineering standpoint.

Responsibilities:

Our client currently has 3  different product lines that they are trying to marry together to introduce a legacy orthopedic product and they are seeking an engineer to support the development and owning of Design History Files. They will be responsible for writing and continuous building of the DHFs for that new product. They will be focusing on new product development in regards to the new technology and design transfer. On a day to day basis, they will draft protocols and reports, perform validation and verification activities, as well as working with design controls and FMEAS. This particular product will involve polymer so someone with exposure to that material would be a strong candidate. Having a background  in Development  coupled with a quality mindset would be the ideal candidate. Also someone who has lead a new product development team would be ideal. 

Required:
  • Medical Device (Class II & III)
  • NPD/NPI
  • Quality Engineering
  • Design Controls
  • V&V

 
  • Plus:
    Mechanical Engineering degree
  • Remediation experience 
  • Lead a new product launch 

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