Job Title: Senior Human Factors Engineer
We are seeking a passionate Senior Human Factors Engineer to join our Global Customer Experience and Solution Design Team (CXSD team) at Roche Diagnostics.
In this role, you will be part of an international group of designers who serve our purpose by designing and enabling a seamless patient-centric experience across our portfolio of products and services.
About the Role:
* You will play a key role in the development of the next generation of medical devices that can diagnose critical diseases.
* You will lead and document studies aimed to provide insights for the development team to improve the design as well as to provide objective evidence that the design outputs of a certain phase in the product development life-cycle are meeting all requirements.
Responsibilities:
* Patient-Centric Approach: Be the voice of patients and Roche users in every product-related discussion.
* User Research: Identify user profiles, tasks, hazard-related use scenarios, usability risks, and requirements.
* UX Design: Translate UX research insights, user needs, business requirements, and technical requirements into pleasant and efficient User Experiences.
* Usability Deliverables: Create medical device usability deliverables according to IEC 62366.
* Workshops and Collaboration: Create and facilitate workshops with the product teams to gather system-level information and to coordinate the design deliverables.
* Usability Studies: Plan formative and summative usability studies and coordinate external suppliers in the process.
* Documentation: Prepare, maintain, and review Usability Engineering Files.
* Accessibility and Quality: Advocate for accessibility, quality, and usability for end-users at Roche Diagnostics.
* Mentorship: Provide guidance and mentorship to more junior designers supporting them on professional development, output, and productivity.
Requirements:
* Degree in Science, Industrial Engineering, Human Factors Engineering, or any other related technical field.
* >5 yrs experience in applied Human Factor Engineering and in Design Control Management.
* Experience in the Usability Engineering process for medical devices (hardware and software).
* Experienced in planning, executing, and documenting usability studies in the medical field.
* Experience collecting and analyzing physiological and behavioral data.
* Knowledge of the IEC 62366 standard and the latest FDA guidance on applying human factors engineering.
* Good knowledge of the ISO 14971 and IEC 62304 would be an advantage.
* Fluency in English.