Medical Devices Technical Expert- Human Factor

MEDICAL DEVICES TECHNICAL EXPERT- HUMAN FACTORS

WE ARE CURRENTLY RECRUITING FOR AN ENGINEER WITH EXPERIENCE IN HUMAN FACTOR AREA TO LEAD HUMAN FACTORS ACTIVITIES DURING THE MEDICAL DEVICE DEVELOPMENT INCLUDING PLANNING AND MANAGEMENT OF HUMAN FACTORS STUDIES, ACCORDING TO CURRENT REGULATIONS AND GUIDELINES.

YOUR RESPONSIBILITIES:

. Providing human factors support throughout the product development life cycle including user needs identification, development of user profiles and use scenarios, task analysis, use-related risk analysis, user interface requirement,
. Planning and managing formative and summative user studies, reporting and presenting design recommendations to the project team.
. Cross-examining and proposing design optimization to enhance ergonomic, usability and safety
. Leading design and development
. Closely collaborate with cross functional stakeholders (eg risk management, Drug Regulatory Affairs, clinical development).
. Supporting Human Factors related documentation for Health Authority registration in collaboration with Drug Regulatory Affairs.
. Works independently against self-set targets when necessary.
. Management of external vendors.

Minimum requirements:
Bachelor's or Master degree in engineering, ergonomics, human factors, usability or related discipline.
Excellent skills in English, verbal and written are required.
Other language skills, eg French, German are advantageous.
Relevant degree and at least 8 years of experience in applying Human Factors Engineering to medical devices development, preferably in the pharmaceutical industry, including.
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

THIS IS 6 MONTHS CONTRACT, BASED IN BASEL

Michael Bailey International is acting as an Employment Business in relation to this vacancy.