Medical Device Technical Expert – Human Factor (m/f)

REFERENZNUMMER:

343947/11

IHRE AUFGABEN:

-Provide human factors support throughout the product development lifecycle, including user needs identification, development of user profiles and use scenarios, task analysis, use-related risk analysis, user interface requirement and instructions for use (IFU)
-Plan and manage formative and summative user studies, reporting and presenting design recommendations to the project team
-Cross-examine and propose design optimization to enhance ergonomic, usability and safety
-Lead IFU design and development
-Support Human Factors related documentation for Health Authority registration in collaboration with Drug Regulatory Affairs
-Management of external vendors

IHRE QUALIFIKATIONEN:

-Bachelor’s or Master degree in engineering, ergonomics, human factors, usability or related discipline
-Excellent skills in English, verbal and written, other language skills, e.g. French, German are advantageous
-Good understanding of medical devices development processes in general
-Specific knowledge in applying Human Factors Engineering processes to medical device development from concept generation to health authority submission
-Experience in developing and documenting Human Factors activities for medical devices as required by regulation
-Experience in project/program management

WEITERE QUALIFIKATIONEN:

Project manager