Human Factors Engineering

Beschreibung

Human Factors Engineer

For our client a market leader in Biotech and Medical Devices, i am currently looking for a Human Factors Engineer with strong expertise in Drug Delivery Devices.
* Project duration: 12 months
* Location: Switzerland

• The Human Factors Engineer is responsible for independently leading human factors activities during the medical device development including the planning and management of human factors studies, according to the current regulations and guidelines.
• The Human Factors Engineer provides human factors support throughout the medical device product development lifecycle including: user needs identification, user studies, development of user profiles and use scenarios, use-related risk analysis, task analysis, user interface requirement and instructions for use (IFU). Plans and manages formative and summative user studies, reporting and presenting design recommendations to the project team.
• Leads IFU design and development
• Works independently against self-set targets when necessary.
• Management of external vendors.
• Cross-examines and propose design optimization to enhance ergonomic, usability and safety Closely collaborate with cross functional stakeholders (e.g. risk management, Drug Regulatory affairs, clinical development)
• Supporting Human Factors related documentation for Health Authority registration in collaboration with Drug Regulatory Affairs.

Requirements:

• Bachelor has or Master degree in engineering, ergonomics, human factors, usability or related discipline.
• Specific knowledge on applying Human Factors Engineering processes to medical device development from concept generation to health authority submission
• Excellent skills in English, verbal and written are required.
• The ideal candidate would have at least 8 years of experience in applying Human Factors Engineering to medical devices development, preferably in the pharmaceutical industry or for drug delivery devices
• Experience in project / program management
• Experience in managing external suppliers for user studies (formative and summative studies)
• Experience in developing and documenting Human Factors activities for medical devices as required by regulation.
• Proven record of accomplishment of successfully managing interfaces to other functions.
• Good understanding of the risk management activities
• Excellent English required (oral & written), German advantageous (oral & written).
• Good communication and problem solving in the team and across organizational boundaries

If this or similar positions could be of interest to you, please don't hesitate contact me or send me your updated CV to:



Best Regards

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