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Your role:
Support the development of AI ultrasound solutions that will advance maternal outcomes and improve global access to obstetric ultrasound.
Create usability engineering plan, develop testing protocols, and facilitate iterative user testing and expert review sessions, using the latest data-driven usability engineering tools and methodologies.
Conduct UFMEA (Use Failure Modes & Effects Analysis) and other Human Factors (HF) analysis to identify risk, errors and failures in the design and workflow. Document UFMEA results and work with stakeholders to create mitigation plan and design improvement.
Define and document usability requirements and work with product manager, clinical experts, systems engineers and other R&D functions to translate usability requirements into product and technical requirements.
Manage formative and summative evaluations and create appropriate documentation as required by regulatory bodies (e.g., FDA, EUMDR, CMDE)
Analyze cognitive, physical, and situational contexts of product use through systems thinking, and maps workflow/task analysis to enhance efficiency and address challenges comprehensively.
Reviews Human Factors Engineering (HFE) reports to showcase completion of usability activities, ensuring the product's safety and efficacy through documented evidence of successful usability engineering processes.
Possess a deep comprehension of development processes and domain expertise, adeptly assesses whether to alter project scope or tackle challenges, prioritizes tasks based on understanding the core challenge and continuously identifies opportunities for improvement.
Offer guidance and suggestions, provide recommendations for design enhancements to user experience designers, product designers, and development teams, aiming to improve product functionality and user satisfaction.
Mentor junior members, spearhead initiatives, ensure efficient operations through guidance, expertise, and collaboration and foster skill development and teamwork.
Preside over meetings with R&D cross-functional teams and interface with (Clinical) Marketing, Design, and Clinical areas, performs tasks such as researching market trends, creating user experience designs, and managing dependencies within relevant processes.
You're the right fit if:
Minimum 13 years of overall work experience
You have acquired 7+ years of relevant experience in usability and have conducted Usability FMEA, formative and summative testing. You have experience developing and testing AI and Machine Learning solutions, preferably.
You have broad knowledge of and experience of the usability engineering process in healthcare/medical or other safety-critical/regulated areas (automotive, aviation, military, etc.) with expert knowledge of usability methodologies, processes and standards, particularly regulatory standards (FDA Applying Human Factors and Usability Engineering to Medical Devices, IEC 62366-1 & 2, ISO 9241-11 (2018), EU-MDR, CMDE). You also have a strong understanding of Risk Management process (ISO 14971).
You have a Bachelor’s or Master’s degree in design research, interaction design, product design, usability, human factors, or human-computer interaction.
You have an affinity for (complex) diagnostic devices and clinical workflows. You are a strong systems thinker, working across hardware, software, and services, to think across an end-to-end customer experience to meet the user’s need and expectations
You have excellent communication, collaboration and execution skills to perform with multidisciplinary and international teams. You have a deep commitment to prioritizing customer needs and enhancing customer experiences in all aspects of your work. Your mindset is entrepreneurial, and you have a track record of working on pioneering innovations.
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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