Beschreibung
To support the development of the medical device team we are seeking a human factors engineer to lead human factors activities in developing medical devices/combination product and digital applications (Android/IOS) 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, labelling and user interface.
Responsibilities:
- Roll out the Human Factors strategy by planning the activities accordingly and performing/documenting the planned activities (eg user studies, design input).
- Provides 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, 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.
Requirements:
- Bachelor's or Master degree in engineering, ergonomics, psychology, human factors, usability, user interface design, industrial design/graphic design or related discipline.
- 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 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
Kontakt: Luchele Mendes
Michael Bailey International is acting as an Employment Business in relation to this vacancy.