Human Factors Specialist
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Medical Devices organization, based in Waadt Switzerland.
They produce Class II medical devices.
As Human Factors Specialist, it's your task to me sure everything related to the Human Factors analysis for the Medical Devices of this client will be taken care of. You will do this both as Consultant of Human Factors / Ergonomics in the Validation Department, Human Factors / Ergonomics R&D Consultant, and overall Human Factors / Ergonomics Subject Matter Expert. This all based on FDA 21 CFR 820.30 and ISO / EN 62366.
- Ensure human factors considerations are embedded into the design of medical devices and software:
- Apply human factors regulations and standards
- Train and support project teams regarding human factors
- Perform early review of user interfaces, instructions for use and training material
- Contribute to the design risk management process
- Lead the development of human factors risk management reports and usability specifications
- Organize and lead human factors exploratory testing
- Coordinate human factors validation:
- Work with human factor testing laboratories
- Define human factor validation strategy
- Supervise human factor testing (formative and summative)
- Review human factors test laboratories protocols and reports
- Contribute to internal human factors summary report
- Write the internal human factors summary report
- Contribute to human factors report (US, FDA, according to FDA 21 CFR 820.30)
- Lead team effort in determining the applicable mitigation actions post human factors testing
- Contribute to human factors post-market surveillance strategy
- Be human factors subject matter expert:
- Be the contact point for question or training on human factors
- Develop/maintain network of human factor experts
- Identify, assess and lead the implementation of new or updated human factors regulations or standards (according to ISO / EN 62366 and FDA 21 CFR 820.30)
- At least 3-5 years of Medical Devices experience
- At least 3 years of Human Factors / Ergonomics experience
- Fluent in English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.