Description
We are looking for a
Medical Device Technical Expert – Human Factor (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- 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
Your qualifications
- 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
Skills:
- Project manager