Human Factors Engineer, Medical Device

Proclinical is working with a well-known medical device company, is currently searching for a Human Factors Engineer in Basel. This is a full-time 6-month contract with possibility of extension.

Job Responsibilities:

• Provide 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.
• Plan and execute formative and summative user studies, reporting and presenting design recommendations to the project team.
• Define appropriate sample sizes and statistical methods for analysis.
• Perform anthropometric, biomechanical, ergonomic, and systems safety analyses to identify and assess risk in product development.
• Cross-examine and optimize developmental prototypes and provides ergonomic, usability and safety assessments for consumer healthcare products, medical devices and pharmaceutical packaging.
• Lead IFU design and development including validation.
• Closely collaborate with cross functional stakeholders (e.g. risk management, Drug Regulatory Affairs, clinical development…).
• Support Human Factors related documentation for Health Authority registration in collaboration with Drug Regulatory Affairs.
• Works independently against self-set targets when necessary.
• Manage of external vendors.

Skills and Requirements:

• 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.
• 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
• Good communication and problem solving in the team and across organizational boundaries.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Owen Bach on +44 203 8261 330 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.