For our client, a global healthcare company, we are lookingforone candidate to fulfill the role ofHuman Factor Engineer
8.This is the approximate number of projects you will work on in the area of digital health, drug delivery devices and combination products to benefit our patients, healthcare providers and their needs for the future. To support the internal capabilities within the development team we are seeking an experienced human factors engineer who leads and monitors human factors activities in development of established and novel software as medical device (SaMD), drug delivery devices and combination products. This includes early concept phase work, formative evaluations to summative human factors evaluation. This position is part of multidisciplinary and international teams, spanning across multiple projects, with human factors engineering being a key element for success. Management of external partners is also an important part of this position.
Your responsibilities:
• Lead the planning, execution, interpretation and reporting of formative and summative human factors evaluations, according to current regulations and guidelines within the medical device and pharmaceutical industry and manage external partners including monitor work progress and budget according to plan.
• Define appropriate sample sizes and methods for analysis of human factors activities.
• Perform anthropometric, biomechanical, ergonomic, and systems safety analyses to identify and assess risk in product development.
• Provide human factors expertise in a broader cross-functional development team including user needs identification, development of user profiles and use scenarios, task analysis, use-related risk analysis, generation of hardware and software design concepts, user friendly system design, operating and training requirements, user interface specification and instructions for use in compliance with both company quality assurance standards and applicable regulations.
• Lead design of user instruction including validation.
• Lead/support creating of internal procedures and templates for the execution of human factors engineering research.
Ideal Background:
• Bachelor degree in Engineering, Psychology, Ergonomics or related discipline/specialty in Human Factors.
• Fluency in English language, succinct writing and communication skills, basic German skills desirable
• Minimum 5+ years of experience in a regulated industry.
• Experience in design of human factors evaluations to address the needs of the requirements setting, design testing, verification and validation stages of device development including documentation.
• Experience in development of HFE principles of ergonomics, human computer/machine interface, and data collection/analysis methodologies.
• Analytical problem solving skills.
• Ability to work in and/or lead teams and to work in a matrix organization.
Desirable:
• Thorough knowledge of relevant human factors regulations, standards and guidelines for medical devices and pharmaceutical packaging. Working understanding the principles of Medical Device and healthcare regulations.
• Expertise in development user interfaces for software as medical device (SaMD).
• Experience in medical device or pharmaceutical industry.
• Ability and experience working with suppliers and contractors.
Please note, that we only accept applicants with Swiss or EU/EFTA citizenship or applicants with an existing and valid residence and work permit for Switzerland.