We are recruiting for a Human Factors Engineer who will be responsible for independently leading the planning, execution and reporting of human factors studies and user interface design according to Medical Device regulations.
Medical Devices under Development: Combination devices with Biosimilars
* Provides human factors support throughout the product development lifecycle including user needs identification, development of user profiles and user scenarios, task analysis, user-related risk analysis, generation of hardware and software design concepts (creation of physical models and prototypes, graphical user interfaces, and product graphics), user interface design and instructions for use.
* Plans and executes formative and summative user studies (studies are outsourced), reporting and presenting design recommendations to the project team.
* Defines appropriate sample sizes and statistical methods for analysis.
* Performs anthropometric, biomechanical, ergonomic, and systems safety analyses to identify and assess risk in product development.
* Cross-examines and optimizes developmental prototypes and provides ergonomic, usability and safety assessments for consumer healthcare products, medical devices and pharmaceutical packaging.
* Leads IFU design and development including validation.
* 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.
* Bachelor’s or Master degree in any discipline. If you come from engineering, ergonomics, human factors, usability or related discipline, then it’s definitely an advantage.
* At least 3 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 excellent communication, negotiating and influencing skills.
* Good deal of flexibility.
Please also note that candidates no not necessarily have to come from Medical Device industry, as long as they possess strong Human Factors/ User interface/ Usability Engineering experience within any highly regulated industry such as aerospace or nuclear.
Please get in touch Luchele.mendes (at the rate of) mbaswitzerland.com or call +41 (0) 44 215 2051
Michael Bailey International is acting as an Employment Business in relation to this vacancy.