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Medical Device Developer / Human Factors Engineer (Clinical Studies) (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Usability, Engineer
Projektbeschreibung
-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
-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)
Weitere Qualifikationen: Clinical trial manager
-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
-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)
Weitere Qualifikationen: Clinical trial manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik