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Engineer I

Company: MILLENNIUMSOFT
Location: San Diego
Posted on: May 28, 2023

Job Description:

Position - - - - - : Engineer I

Location : San Diego, CA

Duration : 11 Months Contract

Total Hours/week :40.00

1st shift



Description:

Principle Duties and Responsibilities:


  • The Engineer 1, MDR Compliance Researcher, will be a specialist from the medical device industry.
  • They will be tasked with preparing/dealing with the gap analysis between usability activities that were and/or must be conducted to fulfill the MDR guidance document.
  • The engineer must have experience with both Human Factors Engineering processes and 510K submissions to be qualified for the role.
  • Ideally, this consultant has a background with Infusion pumps and has dealt with submissions related to those types of devices.
  • They must be able to work independently, as well as with a team of other consultants to get a submission done.




    Required:


    • 5-7 years Regulatory Affairs or 5-7 years Medical Devices
    • Familiarity with Human Factors Engineering
    • 510(k) Submissions experience
    • Infusion Pumps experience is a plus

Keywords: MILLENNIUMSOFT, San Diego , Engineer I, Engineering , San Diego, California

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