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Sr Functional Safety Expert (Medical Devices)

TUV SUD America, Inc


Location:
Minneapolis/St. Paul, Minnesota 55112
Date:
04/10/2017
Job Type:
Employee
Job Status:
Full Time
Categories:
  • Biomedical Engineering
  • Control Systems
  • Electronics Engineer
  • Software Engineering
TUV SUD America, Inc
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Job Details

Reporting to the Program Manager for Medical Device Functional Safety, the Sr. Functional Safety Expert (Medical Devices) is responsible for testing and assessment of complex active medical devices in accordance with European Medical Devices Directives (MDD) and other applicable regulatory systems and international standards. Duties include review and evaluation of customer-supplied technical documentation, report writing, related client and project management activities. A prior role involving training/mentoring of individuals or small teams is highly desirable.

The ideal candidate will have experience in a hardware/software design or testing role within a medical device company or associated industry, and will have detailed knowledge of international medical device standards and regulations. The candidate must have a solid understanding of functional safety design principles, and experience with one or more of the following standards is highly desired:

  • IEC 61508
  • EN ISO 60601-1 and associated particular/collateral standards
  • EN ISO 14971
  • EN ISO 62304
  • IEC 80001-1, 80001-2-2, 80001-2-8

 

Experience with one or more of the following product types is preferred:

  • Infusion Systems
  • Dialysis and Blood Treatment
  • Heart Assist Systems
  • Breathing therapy, anesthesia work stations
  • Defibrillators
  • Devices for stimulation and inhibition
  • Imaging devices utilising ionizing radiation
  • Gamma camera, PET
  • Monitoring devices of vital physiological parameters
  • Devices utilising ionizing radiation
  • Medical lasers, photo-therapy devices
  • Incubators and infant radiant warmers

Requirements

Education

Bachelor’s or higher degree in a technical discipline (engineering, science, mathematics, computing or similar).

Experience

4 years experience within a related role (min 3 years with Masters, min 2 years with PhD)


Skills

Orientation towards the functional safety of medical devices
Correctness
Ability to work in an intercultural environment
Ability to plan and organize work
MS-Office
Common sense and pragmatism
Sound Knowledge in product-, technology- quality- or other related standards
Desired: Working abroad

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