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Manufacturing Enigneer

Position Responsibilities:

Responsibilities may include the following and other duties may be assigned.

    • Ability to summarize data from variety of sources to draft post market surveillance reports on ongoing basis.
    • Lead the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations.
    • Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
    • Represent client as appropriate in FDA, notified body, internal, and other audits.
    • Other duties as assigned or required.

Nice to Have: Preferred Qualifications

  • Experience in vascular devices, embolic coils, stents, catheters, balloons, aspiration devices, coatings and/or guide wires.
  • Extensive knowledge of quality tools:
Risk analysis
Highly proficient in math and use of statistical techniques
Root cause analysis
Problem solving approaches

  • FDA/ISO/MDD/EUMDR requirements and guidance
  • Mastery of relevant software programs preferred - Microsoft Word, PowerPoint, Excel, and Project, and Minitab.

Sthree US is acting as an Employment Business in relation to this vacancy.