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Your role:
You define the usability strategy for the project and lead the usability activities in collaboration with a multidisciplinary team, which includes UI and UX designers, product designers, product managers, clinical marketing, clinical specialists, regulatory managers, quality managers, developers, and system engineers.
You conduct user research, task analysis and create use scenarios.
You create the usability engineering plan.
You analyze post-market data and identify usability issues.
You lead the usability FMEA.
You support the development of user-centered and safe-to-use UI and UX solutions.
You plan, execute and report formative user evaluations and ensure critical findings are fixed.
You conduct summative user evaluation and create the usability engineering file, in compliance with the FDA guidance and IEC62366-1.
You're the right fit if:
You have a degree in human factors engineering, HCI, cognitive science, product/interaction design or other relevant academic background.
You have 3 - 5 years’ experience of usability engineering of complex systems and medical devices from early phases of gathering user needs to late phases of product validation and post market follow-up.
You have experience in conducting task analysis, providing inputs to UI/UX designers, risk managers and engineers, performing and reporting usability evaluations.
You have knowledge and understanding of regulation requirements for usability of medical devices: FDA guidance and IEC62366-1.
You have a good understanding of quality systems (QMS) and risk management principles.
You have knowledge and understanding of cognitive ergonomics principles and physical ergonomics principles.
You have experience in the healthcare domain and experience in clinical workflows e.g. in hospitals, pre-hospital.
You have experience in working effectively in multidisciplinary teams and in a complex global company.
You are highly independent, pro-active and have good communication, presentation, and leadership skills.
You can “speak up” and effectively advocate for user needs and user experience in a global organization.
You write high quality formal documentation in English.
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