This is a remote position.
We are seeking a talented and self-driven UX/UI Designer to create intuitive, compliant, and user-focused digital experiences for regulated medical devices and life sciences applications. This role requires balancing creativity with regulatory discipline translating complex user and technical requirements into clear, safe, and aesthetically refined designs. The ideal candidate combines strong design execution with an understanding of FDA, ISO 13485, and IEC 62366 usability requirements, working closely with cross-functional teams to ensure high-quality, compliant interfaces that support both patient safety and business goals.
Key Responsibilities:
- Lead end-to-end UX/UI design for medical device interfaces, digital tools, and connected systems.
- Develop user flows, wireframes, prototypes, and high-fidelity mockups that communicate design intent effectively.
- Collaborate with Human Factors, R&D, Quality, and Regulatory teams to ensure compliance with usability and design control standards.
- Conduct user research, heuristic evaluations, and usability testing to validate design decisions and ensure optimal user experience.
- Translate user needs and risk analysis findings into traceable design documentation consistent with Design Control (21 CFR 820.30) and IEC 62366-1.
- Design intuitive solutions for data-heavy environments such as dashboards, workflow tools, and device displays.
- Partner with developers to ensure accurate implementation of design specifications and maintain visual consistency across products.
- Bachelor’s degree in Human-Computer Interaction (HCI), Industrial Design, Biomedical Engineering, Cognitive Science, or a related field.
- Professional UX/UI design experience, ideally within medical device, biotech, or pharmaceutical software environments.
- Proven ability to design within regulated frameworks (FDA, ISO 13485, IEC 62366).
- Strong proficiency in Figma, including component libraries, auto-layout, prototyping, and developer handoff.
- Demonstrated portfolio showcasing data-driven interfaces, clinical tools, or device UIs.
- Understanding of human factors engineering, usability validation, and risk-based design documentation.
- Excellent communication skills with the ability to collaborate effectively across multidisciplinary teams.
- Experience designing for embedded systems, touchscreens, or connected IoMT applications.
- Familiarity with front-end technologies (HTML/CSS/JS) to support developer collaboration.
- Working knowledge of ISO 14971 (Risk Management) and IEC 60601-1-6 (Usability Engineering).
- Experience in Agile/MVP product development environments.
- Prior work involving usability studies, design verification/validation, and design history file (DHF) documentation.
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