X-Therma Inc.

Designer

• Translate user needs, workflow insights, and risk controls into clear design requirements and contribute to the creation and review of design specifications, prototypes, and interface concepts.
• Plan, design, and execute usability engineering activities for new and existing medical hardware devices in accordance with regulatory requirements (e.g., MDR, FDA, IEC 62366-1, IEC 60601-1-6).
• Develop and maintain usability engineering files, including user research plans, use specifications, user interface descriptions, task analyses, risk-related use scenarios, and usability validation protocols.
• Create product system architecture visions that align with existing workflows and protocols, and develop these into tangible product concepts together with engineers and external partners.
• Visualize ideas, concepts, storyboards, technical details, and instructions through sketches, drawings, and renderings (analog and digital), and co-create mock-ups, design models, and prototypes with the R&D team.
• Provide guidance on human factors considerations during verification and validation activities and support internal and external audits related to usability engineering.
• Communicate project status, identified usability risks, user feedback, and proposed improvements to management and cross-functional stakeholders.

Usability & Industrial Designer – Medical Hardware Devices