Senior Human Factors Specialist
3 weeks ago
We are seeking an enthusiastic and experienced Human Factors Engineer to support the development of new drug device combination products at GlaxoSmithKline.
The ideal candidate will be part of a dynamic and growing team that are key to delivering an expanding portfolio of injectable devices and more, used for pharma and vaccine drug products.
Key Responsibilities:- Provide inputs for human centred design engineering for a range of projects across all phases of development.
- Be involved in problem solving and utilisation of different strategies to support resolution of design, risk and regulatory challenges.
- Support the execution of early patient handling studies (formative studies), identification and maintenance of user needs, conducting user related risk assessments, planning and execution of design validation activities.
- Support the interface between the external vendors and the Human factors Team.
- Author sections of regulatory files.
- Graduate in Mechanical Engineering, Biomedical Engineering or related degree.
- Practical experience and knowledge of human factors and usability regulatory framework, including FDA guidance, IEC 62366 and ANSI/AAMI HE75 and expectations for medical devices/combination products.
- Experience on the development, manufacture and integration of end user inputs (user needs and risk related scenarios) of medical devices/combination products.
- Working experience in product development and design validation as well as in the regulatory pathways for combination products is desirable e.g. global submissions, agency interactions and authoring dossiers.
- Experience with integration of risk factors and user inputs into device design.
We believe in an agile working culture for all our roles and offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
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