Medical Device Technical Expert – Human Factor
You are a Human Factor Expert with experience in a high regulated industry such as medical devices? Your profession is your passion? You’re a problem solver who is looking for a new challenge? Great!
Our client, an international pharmaceutical company, is looking for you!
You will be responsible for independently leading the planning, execution and reporting of human factors studies and user interface design, according to current regulations and guidelines within the medical device and pharmaceutical industries.
Duties and Responsibilities:
- 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 (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, 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 (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
- 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
- At least 3 years of experience in applying Human Factors Engineering to a high regulated industry such as medical devices, Aeronautic, Nuclear etc. and their respective Quality Systems
- Good understanding of medical devices development processes in general
- Specific knowledge on applying Human Factors Engineering processes to a high regulated industry
- Experience in project/program management
- 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
- Good communication and problem solving in the team and across organizational boundaries
- Good negotiator, presenter, communicator and convincer
- High flexibility needed
We offer you a competitive salary and an interesting challenge in a well named company which will benefit your career.
If you are the person we’re looking for please submit your application. We’re looking forward to getting to know you.