Human Factors Engineer (m/f)

REFERENZNUMMER:

321796/4

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, generation of hardware and software design concepts (creation of physical models and prototypes, graphical user interfaces and product graphics), user interface design and instructions for use
-Plan and execute formative and summative user studies and report and present design recommendations to the project team
-Define appropriate sample sizes and statistical methods for analysis
-Perform anthropometric, biomechanical, ergonomic and systems safety analyses to identify and assess risk in product development.
-Cross-examine and optimise developmental prototypes and provide ergonomic, usability and safety assessments for consumer healthcare products, medical devices and pharmaceutical packaging
-Lead IFU design and development including validation
-Closely collaborate with cross-functional stakeholders (e. g. risk management, drug regulatory affairs, clinical development etc.)
-Support human factors related documentation for health authority registration in collaboration with drug regulatory affairs
-Work independently against self-set targets when necessary
-Management of external vendors

IHRE QUALIFIKATIONEN:

-Bachelor´s or Master´s degree in engineering, ergonomics, human factors, usability or related discipline
-Excellent English language skills (verbal and written) are required, other language skills are beneficial (e. g. French, German)
-Deep experience in applying human factors engineering to medical devices development, preferably in the pharmaceutical industry
-Solid understanding of medical devices development processes in general
-Specific knowledge of applying human factors engineering processes to medical device development from concept generation to health authority submission
-Experience in project/program management and in developing and documenting human factors activities for medical devices as required by regulation
-Proven track record of successfully managing interfaces to other functions
-Experience in managing external suppliers for user studies (formative and summative studies)
-Solid understanding of risk management activities
-Profound communication and problem solving skills in the team and across organisational boundaries

WEITERE QUALIFIKATIONEN:

Application engineer