we are a well-funded medical startup transforming ICU care through advanced technology and innovation. Our smART+ platform is an intelligent, sensor-based solution that optimizes nutrition delivery while reducing the risks of ventilator-associated pneumonia and malnutrition. Supported by clinical trials, we are setting a new standard in critical care by achieving nearly 100% feeding efficiency and reducing ICU stays by an average of 3.3 days. We are seeking an experienced and driven Usability Manager to lead the Human Factors domain throughout the entire product lifecycle. This role operates in a dynamic startup environment and requires close alignment with stringent regulatory standards (FDA / EU MDR). Responsibilities:
* Lead the strategy, planning, and execution of User Experience, User Interface, and industrial design activities, including defining milestones, objectives, and deliverables in compliance with regulatory requirements (FDA, EU MDR).
* Establish and implement structured Human Factors and usability processes, ensuring proper documentation and traceability to support regulatory submissions.
* Collaborate closely with cross-functional teams including R&D, engineering, clinical, regulatory affairs, and Quality Assurance to ensure optimal User Experience aligned with product and system requirements.
* Plan and conduct user research activities to understand user needs, workflows, environments of use, and clinical use scenarios; synthesize insights into actionable design recommendations.
* Design, manage, and execute formative and summative usability studies, including protocol development, data analysis, reporting, and driving design improvements based on findings.
* Provide Human Factors expertise across the entire product lifecycle, including use-related risk analysis, contribution to the Design History File (DHF), and regulatory documentation.
* Lead the strategy, planning, and execution of User Experience, User Interface, and industrial design activities, including defining milestones, objectives, and deliverables in compliance with regulatory requirements (FDA, EU MDR).
* Establish and implement structured Human Factors and usability processes, ensuring proper documentation and traceability to support regulatory submissions.
* Collaborate closely with cross-functional teams including R&D, engineering, clinical, regulatory affairs, and Quality Assurance to ensure optimal User Experience aligned with product and system requirements.
* Plan and conduct user research activities to understand user needs, workflows, environments of use, and clinical use scenarios; synthesize insights into actionable design recommendations.
* Design, manage, and execute formative and summative usability studies, including protocol development, data analysis, reporting, and driving design improvements based on findings.
* Provide Human Factors expertise across the entire product lifecycle, including use-related risk analysis, contribution to the Design History File (DHF), and regulatory documentation.
Requirements:
* Bachelors degree in industrial design, Biomedical Engineering, or a related field. Masters degree – strong advantage.
* 5+ years of experience in Usability / Human Factors within the medical device industry.
* Proven experience leading Human Factors processes in accordance with regulatory guidance, including the U.S. Food and Drug Administration (FDA) and EU MDR requirements.
* Hands-on experience planning and executing user research and usability studies (formative and summative), including protocol writing, data analysis, and preparation of regulatory-ready reports.
* Strong familiarity with relevant standards such as IEC 62366 and ISO 14971, and their implementation within product development processes.
* Experience working in cross-functional product development environments, collaborating with regulatory, quality, clinical, and engineering teams.
* Excellent written and verbal communication skills in English, including the ability to produce regulatory-level documentation.
* Strong leadership skills with the ability to independently drive processes in a fast-paced startup environment.
* Bachelors degree in industrial design, Biomedical Engineering, or a related field. Masters degree – strong advantage.
* 5+ years of experience in Usability / Human Factors within the medical device industry.
* Proven experience leading Human Factors processes in accordance with regulatory guidance, including the U.S. Food and Drug Administration (FDA) and EU MDR requirements.
* Hands-on experience planning and executing user research and usability studies (formative and summative), including protocol writing, data analysis, and preparation of regulatory-ready reports.
* Strong familiarity with relevant standards such as IEC 62366 and ISO 14971, and their implementation within product development processes.
* Experience working in cross-functional product development environments, collaborating with regulatory, quality, clinical, and engineering teams.
* Excellent written and verbal communication skills in English, including the ability to produce regulatory-level documentation.
* Strong leadership skills with the ability to independently drive processes in a fast-paced startup environment.
This position is open to all candidates.
