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For our client, a world leader in Diagnostics, we are looking for a Human Factors Engineer (HFE) located in the Lucern / Zug area, Switzerland, in a contracting setting of 1 year, extension possible.
As a Human Factors Engineer (HFE), you will play a key role in the development of the next generation of medical devices that can diagnose critical diseases. You will be responsible for orchestrating and documenting 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. As part of the HFE team, you will play a key role in assisting the project teams assess the quality and quantity of HF work required to pass internal milestones and ultimately gain acceptance from regulatory bodies.
Profile
* Analyze user profiles, tasks, hazard-related use scenarios, usability risks, and requirements
* Responsible for creating medical device usability deliverables according to IEC 62366 and the FDAs guidance on HFE
* Create and facilitate workshops with the product teams to gather system-level information and to coordinate the design deliverables
* Plan formative and summative usability studies and coordinate external suppliers in the process
* Prepare, maintain and review Usability Engineering Files for multiple products
* Advocate for safety, efficacy, accessibility, quality and usability for end-users at Roche Diagnostics
* Provide guidance and mentorship to more junior designers supporting them in professional development, output, and productivity
Requirements
* Masters in Science, Industrial Engineering, HFE or other technical field
* 5+ years experience in applied HFE, Design Control Mgt within Medical device / IVD
* Experience in the Usability Engineering process for medical devices / IVD, and in planning, executing and documenting usability studies in the medical field
* Good knowledge of the ISO 14971, IEC 62304
* Experience collecting and analyzing physiological and behavioral data, and in creating, facilitating and analyzing workshops with customers / stakeholders
* You have excellent presentation skills and the ability to communicate know-how, experiences, ideas, solutions and deliverables effectively and persuasively
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