Human Factors Engineer
The successful candidate will lead human factors activities within medical device development projects.
The Human Factors Engineer will be responsible for independently leading, planning, executing and reporting human factors activities to be performed during the development of medical device/combination product as required by the current relevant regulations. It includes managing user studies and informs the user interface design to fulfil the user needs. Additionally in this senior role the successful candidate will independently lead specific area of development across different projects.
In this position it is expected that the successful candidate:
- 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 (creation of physical models and prototypes, graphical user interfaces, and product graphics), user interface design and instructions for use.
- Plans and manages formative and summative user studies, reporting and presenting design recommendations to the project team. This includes management of external vendors.
- Performs anthropometric, biomechanical, ergonomic, and systems safety analyses to identify and assess risk in product development.
- Cross-examines and proposes design optimization by providing ergonomic, usability background information
- Leads IFU/training video design and development and evaluation in user studies
- Closely collaborates with cross functional stakeholders (e.g. risk management, Drug Regulatory Affairs, clinical development…).
- Supports Human Factors related documentation for Health Authority registration and leads discussion with health authority
- Works independently against self-set targets and team targets
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, e.g. French, German are advantageous.
The Ideal Candidate Would Have
- Relevant degree and 5-8 years of experience in applying human factors engineering to medical devices development, preferably in the pharmaceutical industry,
- 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 English required (oral & written), German advantageous (oral & written).
- Good communication and problem solving in the team and across organizational boundaries.
GXP CONSULTING Switzerland is specialized in Life Sciences and provides high quality support and expertise to its customers through a full range of services all along the product lifecycle. Thanks to our extensive experiences, we offer pragmatic solutions in areas such as Quality Assurance, Regulatory Affairs, Operational Excellence, Engineering, Process Engineering, Manufacturing and Maintenance, Project Management, Human Factors/Usability and trainings…
If you have exceptional technical skills, a great personality and you are passionate about serving others, then GXP CONSULTING Switzerland is the right place for you.
Qualified candidates must be legally eligible to work for any employer in Switzerland. Please submit your application to: email@example.com