Description
We are looking for a
Medical Device Developer / Human factors engineer (Clinical studies) (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Place: in Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Perform empirical research with human research subjects to investigate usability of medical devices (used in clinical trials)
- Write and set up instructional materials for internal use (for use in clinical trials and trainings) and for external use (final labeling materials subject to approval of health authorities)
- Report study results to management
- Perform use related risk analysis
Your qualifications
- Relevant experience in human factors studies for medical devices
- Relevant experience with combination product development
- Know-how of performing use related risk analysis (e.g. FMEAs)
- Know-how of designing formative and summative usability studies, including protocol development, IRB/Ethics Committee submissions, data analysis and report writing
- Knowledge of Norms: ISO 13485 and 14971, IEC 62366, AAMI/ANSI-HE-75
- Knowledge of statistical programs (e.g. SPSS)
Skills:
- Clinical trial manager
Keywords: Clinical Trial Manager medical devices human factors studies FMEA SPSS IRB clinical studies