An exciting opportunity has arisen at a global pharmaceutical company which has a diverse team of highly specialised engineers and scientists responsible for the design, industrialisation and testing of medical devices and drug delivery systems. Human Factors Engineering and Usability are vital elements in the innovation and development of our products.
- As a key player within Global Device Developments User Interface team you will define bespoke Human Factors strategy for multiple programs, meeting global regulatory requirements and reflecting the latest regulatory and industry thinking. The User Interface team develop user-related Design Input requirements and lead user-focussed Risk Assessments working in compliance with our Quality Management System.
- In collaboration with cross functional partners you will develop and execute human factors programs from early formative assessments to definitive home-use and validation studies. Your findings will inform and guide device development activities and will provide key evidence to the device risk management program. Throughout each program of work, you will ensure that the Human Factors program is accurately reflected in the device development plan and you maintain the feedback loop into design and risk management. You will be an integral member of the device development program teams.
- The Human Factors Specialist will be responsible for the development and execution of the Design Validation Plan and will be a key contributor to the resulting regulatory submissions.
- We are looking for a candidate who will lead collaborations, maintain an awareness of the device development landscape and who has the technical drive and confidence to represent the company in the external environment.
Skills and Requirements:
- Demonstrable experience of working under device design controls specifically in Human Factors / Usability Engineering / User-focused Risk Management.
- Strategic thinking in the inter-relationship between usability and device design and development.
- Experienced in ISO and FDA regulations and standards as applicable to device usability and regulatory patient-focused labelling development.
- Experience in development of usability/human factors study plans and protocols.
- Appropriate Science, Engineering or Psychology Degree.
- Excellent verbal and written communicator; clear and concise in communications with internal and external partners.
- Proficiency in speaking, comprehending, reading and writing English is required.
- Experience in the development of Combination Products/ Drug Device Systems within the medical device or pharmaceutical industry.
- Experience in leading usability studies from study design, planning, execution and reporting within medical device or pharmaceutical industry.
- Experience of Design Iteration and Applied Design.
- Knowledge of graphic design and associated software packages
- Travel within Europe & US appropriate to project requirements, averaging 20% of working year.
- Regular travel between the Dublin, Cambridge (UK) and Sandwich (UK) sites.
- Ability to work flexibly across a multi-disciplinary team in jointly achieving departmental goals.
- Attention to detail in working approach.
- Strong team player that is willing to take on and support other activities outside core expertise as required to develop the future of the department.
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 Harry Williams on +41 203 854 0102 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.