Ability to translate requirements into mockups, wireframes and visuals leveraging input from engineering, clinical, marketing, regulatory and human factors.
Generate iterations of the user interface design to be evaluated by cross-functional teams.
Ability to design user experiences though the creation of interaction flows, design patterns and medium to high fidelity prototypes.
Produce and maintain pixel perfect graphics, graphical components and graphics asset libraries.
Must be able to provide technical solutions that reflect understanding business objectives and cost implications.
Ability to resolve competing constraints between interrelated functions (Engineering, Risk Management, Compliance, Reliability, Clinical, Human Factors, Regulatory).
Requirements:
BA/BS required in related field
Experience with the medical devices or medical software.
Experience with Medical Device design controls and understanding of Good Document / Manufacturing Practices in the area of design controls, including FDA-21 CFR 820.30 and ISO 9001.
Candidate must have expertise in ISO-EN-IEC60601-1, IEC 62304, ISO 14971 (Class 1 & Class 2 Devices) Visio, Value Engineering ISO 13485
Working understanding of IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
