Junior Human Factors EngineerSwitzerlandR-1104421095 CSL Behring AG (CH)
With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In Bern more than 1600 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide.
For our location in Bern, for the Impurity and Data Management team within Technical Operations R&D department we are looking for a
Human Factors Engineer (100%) (m/f/d)
We are looking for a Human Factors Engineer who can support us in great projects related to Combination Products and Medical Devices. In this role you will collaborate with multifunctional, inter-disciplinary teams and will apply Human Factors (HF) process to meet usability, safety and regulatory requirements for Medical Devices and Combination Products.
Main Responsibilities and Accountabilities:
- Develop and execute Human Factors Engineering plans as per current standards and guidelines (e.g. FDA HFE Guidelines, IEC 62366, EN ISO 14971, AAMI HE75, 21 CFR part 820, etc.).
- Conduct risk analysis of Medical Devices and Combination Products.
- Write and review HF study protocols (formative and summative studies).
- Supervise studies’ execution.
- Conduct users’ research (empirically through field studies, experimental set-ups, or by means of literature reviews and analyses, anthropometric research).
- Write and assess instructional and training material for end-users and patients.
- Analyze post-marketing data in light of usability and ergonomics standards and requirements.
- Participate to development/project team meetings as HF subject-matter expert, provide input on HF compliance and HF topics.
- Present the results of the studies to projects’ teams and stakeholders.
Qualifications & Experience:
- Bachelor or Master degree in Psychology, Cognitive Psychology, Social Sciences with focus on Human-Computer Interaction (HCI), or related discipline.
- A first experience in the medical device industry (pharma, biotech) or in a regulated industry with focus on safety-critical systems would be an advantage.
- Capable of writing and reviewing studies’ protocols (English language) and study reports that involve human subjects, ensuring that methodological rigor and subjects’ safety is maintained.
- Demonstrated ability of analyzing empirical data in light of theories on human errors.
- Demonstrated ability to interpret studies’ results and to use them pragmatically as actionable inputs for products’ design.
- Practical knowledge of statistics.
- Knowledge of usability/HF standards for combination products and medical devices.
- Prior experience in the field of medical devices, combination products or health sciences industry is strongly preferred.
We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.
CSL Behring is committed to provide equal employment opportunity for all.