Human Factors Engineer
ProClinical is happy to announce that a vacancy has emerged for a Human Factors Engineer position in a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company's products and services are used to help care for critically and chronically ill patients.
In this role, the Human Factors Engineer is responsible for defining and leading Human Factors and Usability Engineering, including Use Risks, along with activities in Projects with a focus on timelines, budgets, quality, and risk management. This fixed-term contract role is with the company's Swiss team in Nyon.
- Designing and planning HFE programmes for multiple projects in close relationships with project leads, engineering, industrial design, quality, marketing and regulation both internal and external to the company.
- Working as a project team member supporting multiple projects by conducting use risk assessments, designing and conducting use needs identification work.
- Ensuring that the device product development process follows Human Factors best practices.
- Identifying use risks and conducting related analysis and reporting.
- Ensuring appropriate documentation for Human Facts are delivered.
- Understanding future unmet needs and ensuring that a knowledge of best practice is maintained.
- Maintaining Human Factors processes and procedures according to regulations and best practices.
- Designing and conducting Human Factors studies globally.
- Selecting and managing human Factors consultants/consultancies where required.
- Identifying use needs and requirements.
- Ensuring any design is user-centred.
- Writing Human Factors reports for design history files and submissions.
- Maintaining Use Risk documentation during all development stages.
Skills and Requirements:
- A degree or higher in Human Factors, Ergonomics, Psychology, Usability, Industrial Design or in a related field.
- A significant experience of device development, applying various human factors engineering principles and methodologies, user needs analysis and validation studies are required.
- A knowledge of Human factors standards, guidance and best practices, along with an understanding of drug/device combination regulatory requirements, as well as knowledge of product design from concept to commercialisation.
- Experience in the creation of regulatory submission reports for medical devices and combination products is preferred; as is a practical experience-based in-depth knowledge of EU and FDA regulatory requirements.
- An ability to work in multiple projects in multi-disciplinary teams across multiple global locations.
- A thoroughness in managing use risk assessments and maintaining risk related documentation.
- Proficiency with MS Office (Excel, Outlook, Word) and internet functions.
- Demonstrable communication, organisational, project management and multi-tasking skills.
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 Joshua Godden on +44 2038540101 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.
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