UX Designer & Usability Engineer (UX + HFE/UE) (60-80%)
machineMD
- Berne
- CDI
- Temps-plein
Our flagship device, neos™, is the world’s first neuro-ophthalmoscope—delivering rapid, quantitative, and objective exams using VR and AI-driven eye tracking to measure brain function.Join us and shape the future of neurological diagnostics in a team that values conscious leadership, self-organisation, and purposeful innovation.TasksWe’re looking for a versatile person somewhere between UX Design and Human Factors who can support product design and usability engineering. The goal is to collaborate with medical experts to translate clinical workflows into intuitive interfaces and validate them according to HFE/UE processes in line with Medtech regulatory standards (IEC 62366-1 & FDA guidance).
We welcome applications from specialists on either side (UX or HFE/UE); the final scope and title can be tailored to your strengths.Key ResponsibilitiesUX Design
- Discover & define: Lead contextual inquiry, stakeholder interviews, and journey mapping to understand clinical workflows and constraints.
- Information architecture & flows: Translate insights into task models, user flows, and navigation for VR and desktop touchpoints.
- Prototype & iterate: Create wireframes and high-fidelity prototypes (e.g. Figma); run design reviews; refine based on feedback and data.
- Visual- & interaction design: Design user-friendly visualizations of numeric information, using either established visualization formats or innovative approaches. Deliver production-ready layouts and specs for software and hardware teams.
- Cross-functional collaboration: Partner closely with Commercial, Development and Clinical Affairs to ship designs that balance usability, feasibility, and business impact.
- Planning: Own the Usability Engineering Plan; define intended users, use environments, and critical tasks for class II devices.
- Risk-based analysis: Perform task and use-error analyses; identify hazard-related use scenarios; link mitigations into ISO 14971 risk management.
- Formative evaluations: Plan and conduct heuristic reviews, expert walkthroughs, and simulated-use studies; translate findings into design inputs.
- Summative validation: Design and run final usability validation according to FDA guidance and IEC 62366-1; justify sample sizes; analyse results; compile FDA/notified body-ready HFE/UE Reports.
- Documentation & traceability: Maintain the Usability Engineering File; ensure clean traceability between user needs, design inputs, risk controls, verification and validation (aligned with ISO 13485 design control).
- Labelling & training: Contribute to IFU, on-device labelling, and training materials; verify they reduce critical use errors.
- Regulatory support: Provide HFE/UE evidence for 510(k) and CE technical documentation; liaise with regulators and Notified Bodies as needed.
- Post-market inputs: Support complaint/use-error trending and CAPA from a usability perspective.
- Degree in Human Factors/Ergonomics, UX/HCI/Interaction Design, Biomedical Engineering, Cognitive Psychology, Neuroscience or related field.
- 3+ years in UX and/or HFE/UE for complex products; experience with regulated medical devices strongly preferred.
- HFE/UE: Working knowledge of IEC 62366-1/-2, FDA HFE/UE guidance, ISO 14971, and ISO 13485 (or the ability to ramp quickly).
- UX: Hands-on experience with iterative design process and prototyping tools (e.g., Figma, usability test platforms; Unity or similar for VR design is a plus).
- Experience with VR/AR, eye-tracking, or neuro-ophthalmology is a plus.
- Collaborative, detail-oriented, and comfortable in a fast-paced, self-organized environment.
- Clear, structured communicator in English (written and spoken); German and/or French is a plus
- Willingness to travel occasionally (<10%) for research and validation.
- Meaningful impact– Help bring breakthrough neuro-diagnostic technology to doctors and patients worldwide.
- Collaboration and personal responsibility– Decision making and accountabilities are distributed based on defined roles of each team member and are facilitated by mutual respect and strong peer support.
- Growth and learning– Work with highly motivated clinical-, commercial-, regulatory-, AI- and software experts and profit from conferences and courses.
- Flexibility– Hybrid setup with one anchor office day (Monday); work-life balance built into how we operate.
- Global connections– Collaborate with colleagues and partners in Bern, Boston, and beyond.