Plan and execute Human Factors Engineering (HFE) activities for drug delivery devices, including secondary packaging and Instructions for Use (IFU)
Develop HFE documentation, including Use Risk Assessments, Design History (DHF) deliverables and regulatory submission documentation
Support the planning and execution of formative and summative usability studies
Analyse user capabilities and known use-related problems to improve device usability and safety
Collaborate with HFE leads and cross-functional teams to ensure project delivery and regulatory compliance
Ensure compliance with relevant regulations, standards and guidance, particularly IEC 62366

Degree in Ergonomics, Psychology, Science, Engineering or a related field
Minimum 5 years of relevant pharmaceutical industry experience or equivalent academic experience, ideally involving combination products and drug delivery devices
Strong expertise in Human Factors Engineering, IEC 62366, Use Risk Assessments and Instructions for Use development
Experience with nebulizer technology is strongly preferred; experience with injection devices is an advantage
Knowledge of regulatory and quality standards, including documentation for regulatory submissions
Independent, structured and proactive working style with strong communication and collaboration skills
Fluent English skills

Human Factors Engineer

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