To support the development of the medical device team we are seeking a human factor engineer to lead human factors activities in developing medical devices/combination product and apps from early phase to late phase development.
This position is part of multidisciplinary and international teams, spanning across multiple projects, with human factors engineering being a key element for success.
The Human Factors Engineer will provide expert input to the device development teams to establish system, design, operating requirements, support design of packaging, labeling and user interface.
• The candidate will be responsible for independently leading, planning, executing and reporting of human factors studies with users to evaluate the user interface design and propose improvement.
• Roll out the Human Factors strategy by planning the activities accordingly and performing/documenting the planned activities (e.g. user studies, design input).
• Communication and negotiation skills are key to influence diverse stakeholders
Typical activities are:
• Provides 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, generation of instruction for use (creation graphical user interfaces, and product graphics), user interface design and instructions for use.
• Plans and executes formative and summative user studies, reporting and presenting design recommendations to the project team either using external vendors or using internal facilities.
• Design Instruction for Use and User Interface
• Performs anthropometric, biomechanical, ergonomic, and systems safety analyses to identify and assess risk in product development.
• Propose design optimization of the developed product.
• Bachelor’s or Master degree in engineering, ergonomics, psychology, human factors, usability, user interface design, industrial design/graphic design or related discipline.
• Excellent skills in English, verbal and written are required.
An ideal candidate would have a relevant degree and 5 to 10 years of experience in applying Human Factors Engineering/usability to medical devices development, preferably in the pharmaceutical industry, including:
• Good understanding and 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 apps, software and/or industrial design
• Experience in managing user studies (performed by vendors or self-managed)
• Experience in developing and documenting Human Factors activities for medical devices as required by regulation
• Good understanding of the risk management activities