Remediation Engineer

Company: Modis
Location: Bloomington
Posted on: August 7, 2022

Job Description:

A Remediation Engineer [remote] position in Bloomington, Indiana is available courtesy of Modis Engineering.Responsibilities:

• Managing and performing work to augment the design files in support of a submission.
• Focus on the engineering responsibilities for this project.
• Position report to engineering management (team leaders) and interact directly with a cross-functional working group including Regulatory, QA and SBU, which will be responsible for the submissions.
• Work will be performed on-site.
• Ability to travel to external facilities (including out of the country facilities) as necessary.Qualifications:
  • Must have an engineering degree and also 1+ years of experience with Design History Files.
  • Extensive work experience within the medical device / FDA regulated industries.
  • Strong engineering and technical expertise.
  • Extensive DHF experience, with a variety of medical devices.
  • Familiar with cGMP, ISO 13485, ISO 14971.
  • Technical acumen to work with team engineers to identify/conduct remediation activities.
  • Very conscientious / detail-oriented individuals / strong team leadership skills.
  • Applicants must be currently authorized to work in the United States on a full-time basis. This assignment does not allow sponsorship. Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Keywords: Modis, Bloomington , Remediation Engineer, Engineering , Bloomington, Indiana