Senior Human Factors Engineer (m/f/d)

Senior Human Factors Engineer (m/f/d) - IEC 62366 / FDA / ISO 14971 / IEC 62304 / English

Project: For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a qualified Senior Human Factors Engineer (m/f/d)

Background: Roche Diagnostics Global Customer Experience and Solution Design Team (CXSD team) is looking for a passionate Senior Human Factors Engineer to redefine Roche User Interface and Product design and transform the Healthcare industry for the better. At CXSD you will join an international group of designers that serve our purpose to bring the voice of customers to the core of Roche Diagnostics decisions by designing and enabling a seamless patient-centric experience across our portfolio of products and services. You'll be part of building design maturity for Roche with peers who are passionate, energetic and caring in a connected, multicultural, highly motivated team. As a Human Factors Engineer 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 to 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.

The perfect candidate has more than 5 years of experience in applied Human Factor Engineering and in Design Control Management. Additionally, the person is experienced in the usability engineering process for medical devices made of both hardware and software, as well as in planning, executing and documenting usability studies in the medical field. Also, the person is knowledgeable of the IEC 62366 standard and the latest FDA guidance on applying human factors engineering. Finally, the candidate communicates fluently in English.

Tasks & Responsibilities:
• Be the voice of patients and Roche users in every product related discussion
• Identify user profiles, tasks, hazard-related use scenarios, usability risks and requirements
• Responsible for translating UX research insights, user needs, business requirements and technical requirements into pleasant and efficient User Experiences
• Responsible for creating medical device usability deliverables according to IEC 62366
• 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
• Advocate for accessibility, quality and usability for end-users at Roche Diagnostics
• Provide guidance and mentorship to more junior designers supporting them on professional development, output and productivity

Must Haves:
• Master's degree in Science, Industrial Engineering, Human Factors Engineering or other related technical field
• Min. 5 years of experience in applied Human Factor Engineering and in Design Control Management
• Experience in the Usability Engineering process for medical devices made of both hardware and software
• Experienced in planning, executing and documenting usability studies in the medical field
• Experience collecting and analyzing physiological and behavioral data
• Experience in creating, facilitating and analyzing workshops with customers and stakeholders
• Excellent presentation skills and ability to communicate know-how , experiences, ideas, solutions and deliverables effectively and persuasively
• Knowledge of the IEC 62366 standard and the latest FDA guidance on applying human factors engineering • Fluency in English. Other languages are always a big plus.

Nice to have:
• Good knowledge of ISO 14971 and IEC 62304

Reference No.: 923539TP
Role: Senior Human Factors Engineer (m/f/d)
Industry: Pharma
Workplace: Rotkreuz
Working hours: 80-100%
Start: 01.09.24
Duration: 36++
Deadline: 23.07.24

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com . Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01 .

About us: ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering. We offer staff leasing & payroll services. For our candidates this is free of charge, also for payroll we do not charge you any additional fees.