Human Factors Engineer

Human Factors Engineer Location - Rotkreuz Duration 1 year (definite chance to extend) Pay rate max. 100 CHF / h Workload : 80-100% Remote / Home Office : 1 day / week on-site required - upon project expectations.

Travel : 5% international travel (most likely US and Europe)*You’ll be part of building design maturity for organisation 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.
• Tasks & Responsibilities : Be *the voice of the organisation’s patients and users in every product related discussion. Analyse 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 in the organization.
• 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 another related technical field* 5+ years’ experience in *applied Human Factor Engineering and in Design Control Management *5 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. 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 analysing physiological and behavioural data*.

You have experience in *creating, facilitating, and analysing 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.* IVD experience is a big plus.*For further details, please contact Rudo Urayayi on +44(0)1727 817 616 or email a copy of your CV to [email protected]*
Il y a 16 jours