Human Factors Engineer

Coopers Group AG seeks a Mid-level Human Factors Engineer in Zug to lead usability engineering for medical devices, ensuring compliance with IEC 62366 and advocating for user needs.

This position serves as the primary advocate for patients and internal stakeholders during product development. The engineer translates user research and needs into efficient, compliant user experiences while guiding design decisions to ensure safety and usability.

Responsibilities

• Define user profiles, tasks, and hazard-related scenarios to identify usability risks and requirements.
• Develop and maintain medical device usability documentation in accordance with IEC 62366 standards.
• Organize and lead workshops with product teams to collect system-level data and align design outputs.
• Design and manage formative and summative usability studies, including coordination with external vendors.
• Prepare, update, and audit Usability Engineering Files to ensure regulatory compliance.
• Champion accessibility, quality, and usability principles across the organization.
• Mentor junior designers and provide technical guidance on human factors best practices.

Requirements

• Master’s degree in Science, Industrial Engineering, Human Factors Engineering, or a related technical discipline.
• At least five years of professional experience in applied Human Factors Engineering and Design Control Management.
• Proven track record in the Usability Engineering process for medical devices involving both hardware and software components.
• Demonstrated ability to plan, execute, and document usability studies within the medical sector.
• Experience in collecting and analyzing physiological and behavioral data.
• Skilled in creating, facilitating, and analyzing workshops with customers and stakeholders.
• Strong presentation abilities with a capacity to communicate complex ideas, solutions, and deliverables persuasively.
• Solid understanding of the IEC 62366 standard and current FDA guidance on human factors engineering.
• Fluent proficiency in English.

Nice to have

• Familiarity with ISO 14971 and IEC 62304 standards.