StellenbeschreibungbJobdescription /bbr /pWe are looking for an engaged, quality-minded Human Factors Engineer (m/f/d) to strengthen an international Customer Experience and Solution Design team for our client, a leader in the medical device and in-vitro diagnostics industry based in Rotkreuz.br /br /br / /ppIn this role, you will play a key part in the development of next-generation medical devices that diagnose critical diseases by bringing the voice of patients and users to the core of product design decisions. You will lead and document usability studies to guide development teams, ensure seamless hardware and software user experiences, and provide objective evidence that product designs meet all regulatory human factors requirements within a regulated medical environment.br /br /br /br /br / /ph3General Information /h3br /br / ullipStart Date: (Latest possible start date: ) /p /lilipDuration: 1 year (with option for extension) /p /lilipWorkplace: Rotkreuz /p /lilipWorkload: 100% /p /lilipHome Office: Yes, available (up to 3 days per week) /p /lilipTravel Activity: Yes, 5–10% (mostly within Europe)br /br /br /br /br /br / /p /li /ulh3Tasks Responsibilities /h3br /br / ullipUser-Centric Design Advocacy: Act as the voice of patients and users in all product-related discussions; translate UX research insights, user needs, business goals, and technical parameters into pleasant and efficient user experiences. /p /lilipRequirements Risk Analysis: Identify user profiles, tasks, hazard-related use scenarios, usability risks, and specific user requirements. /p /lilipUsability Engineering Compliance: Responsible for creating, maintaining, and reviewing Usability Engineering Files and deliverables according to IEC 62366. /p /lilipUsability Testing Study Management: Plan, execute, and document formative and summative usability studies in the medical field, coordinating with external suppliers throughout the process. /p /lilipWorkshop Facilitation Team Collaboration: Create and facilitate workshops with cross-functional product teams to gather system-level information and align on design deliverables. /p /lilipMentorship Quality Standards: Advocate for accessibility, quality, and usability across product lines while providing guidance and mentorship to junior designers to support their professional development and output.br /br /br /br /br / /p /li /ulh3Qualifications Requirements (Must-Haves) /h3br /br / ullipEducation: Master’s degree in Science, Industrial Engineering, Human Factors Engineering, or a related technical field. /p /lilipHuman Factors Design Control Experience: Min. 5 years of applied experience in Human Factors Engineering and Design Control Management within a regulated environment. /p /lilipMedical Hardware Software Usability: Hands-on experience navigating the Usability Engineering process for medical devices encompassing both hardware and software systems. /p /lilipUsability Studies Data Analysis: Proven track record in planning, executing, and documenting usability studies in the medical field, including collecting and analyzing physiological and behavioral data. /p /lilipRegulatory Knowledge: Solid understanding and practical application of the IEC 62366 standard and the latest FDA guidance on applying human factors engineering. /p /lilipCommunication Facilitation Skills: Excellent presentation skills with demonstrated success creating, facilitating, and analyzing workshops with stakeholders; fluent in English (spoken and written).br /br /br /br /br /br / /p /li /ulh3Desirable Skills (Nice-to-Haves) /h3br /br / ullipComplementary Medical Standards: Working knowledge of risk management (ISO 14971) and medical device software standards (IEC 62304). /p /lilipMultilingual Capability: Proficiency in additional languages alongside English is a strong plus. /p /li /ul
