Human Factors Engineer (f/m/d)

Human Factors Engineer (f/m/d) – Design Control Management/ Usability Engineering/ medical devices/ ISO 14971, IEC 62304/ English

Project :
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Human Factors Engineer.

Background:
Roche Diagnostics Global Customer Experience and Solution Design Team (CXSD team) is looking for a passionate Human Factors Engineer (HFE) 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 orchestrate 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. As part of the HFE team you will play a key role in assisting the project teams assess the quality and quantity of Human Factors work required to pass internal milestones and ultimately gain acceptance from regulatory bodies.

The perfect candidate:
The perfect candidate has a Master degree in human factor engineering as well as at least 7 years of experience in both product development and human factor engineering within the MedTech environment. The candidate should have a profound knowledge of risk analysis.

Tasks & Responsibilities:
– Be the voice of Roche patients and users in every product related discussion
– 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 Human Factors Engineering
– 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 on professional development, output and productivity

Must Haves:
– You hold a MS in Science, Industrial Engineering, Human Factors Engineering or other related technical field
– 7+ years experience in applied Human Factor Engineering and in Design Control Management
– You have experience in the Usability Engineering process for medical devices
– You are experienced in planning, executing and documenting usability studies in the medical field.
– You have good knowledge of the ISO 14971, IEC 62304
– You have experience collecting and analyzing physiological and behavioral data.
– You have experience in creating, facilitating and analyzing workshops with customers and stakeholders
– You have excellent presentation skills and ability to communicate know-how, experiences, ideas, solutions and deliverables effectively and persuasively
– You are fluent in English.

Nice to have:
– Other languages ​​are always a big plus

Reference No. : 922416SDA
Role : Human Factors Engineer
Industry : Pharma
Workplace : Rotkreuz
Workload : 100%
Start : ASAP
Duration : 12++
Deadline : 24.05.2023

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 specializes 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, so for Payroll we do not charge you any additional fees.