Medical Device Technical Expert - Human Factor

Beschreibung

Medical Device Technical Expert - Human Factor

Start: to

Duration: 6 months (possible extension)

Location: Basel

Main Tasks:

• The Human Factors Engineer will be responsible for supporting planning, execution and reporting of human factors studies and user interface design, according to current regulations and guidelines within the medical device and pharmaceutical industries.
• Provides human factors support/documentation 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, user interface design and instructions for use.
• Plans and executes formative and summative user studies, reporting and presenting design recommendations to the project team.
• Support use related risk analysis during product development.
• Support IFU design and development.
• Closely collaborate with cross-functional stakeholders (e.g. risk management, Drug Regulatory Affairs, clinical development…).
• Works independently against self-set targets as necessary.

Requirements for the role are:

• Good understanding of medical devices development processes in general.
• Specific knowledge on applying Human Factors Engineering processes to medical device development from concept generation to health authority submission.
• Experience in project / program management.
• Experience 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)
• Good understanding of the risk management activities
• Good communication and problem solving in the team and across organizational boundaries

Professional Experience:At least 3 years of experience in applying Human Factors Engineering to medical devices development, preferably in the pharmaceutical industry.

Education: Bachelor's or Master degree in engineering, ergonomics, human factors, usability or related discipline.

Language: Excellent skills in English, verbal and written are required. Other language skills, e.g. French, German are advantageous.

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.