We areseekinga highly skilledHuman Factors Expertto join our team in the development ofdrug/device combination products. The ideal candidate will have extensive experience inhuman factors engineering (HFE)andusability studiesforprefilled syringes, autoinjectors, and related delivery systems. This role ensures that our products meet regulatory requirements, are safe, effective, and user-friendly for patients and healthcare professionals.
Key Responsibilities:
1. Strategize and leadhuman factors engineering activitiesthroughout thecombinationproduct development lifecycle.
2. Develop and executehumanfactorsstudy plans, including formative and summative usability studies, risk analyses, and validation protocols.
3. Collaborate with cross-functional teams (CMC,Quality, Regulatory, Clinical) to integrate user needs into design requirements.
4. Conducttask analyses, user research, and use-related risk assessmentstoidentifypotential use errors and mitigate risks.
5. Provideexpertiseondevice usability for patients with chronic conditions, considering physical and cognitive limitations, in consultation with medical and clinical experts.
6. Preparehuman factors documentationfor regulatory submissions (FDA, EMA), includingHuman Factors Engineering Reports.
7. Ensure compliance withFDA guidance on human factors,ISO 62366, and other relevant standards.
8. Supportdesign verification and validationactivities fordrug delivery systems such asprefilled syringes, autoinjectors, and other injection devices.
9. Stay current withindustry trends, regulatory expectations, and best practicesin human factors and usability engineering.
Required Experience & Skills
10. Proventrack recordinhuman factors/usability engineering,project management, andcross-functional leadership.
11. Deep understanding of human factors engineering and its application incombinationproduct development.
12. Familiarity with globalregulatory frameworksfor medical devices and combination products.
13. Strong interpersonal andcommunicationskills; ability to energize and align diverse teams.
14. Experience with autoinjector platforms (e.g.,YpsoMate) is a plus.
15. Ability to work in a cross-functional, global environment.
Company Values Alignment
Candidates should embodyargenx’score values: co-creation, humility, excellence, innovation, and empowerment.
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Note: The recruiter will share the locally applicable annual base salary hiring range, provided in your country’s currency, during the recruitment process. This information will reflect market conditions, role scope, and internal guidelines specific to your location.
This job is eligible to participate in our short-term and long-term incentives program.
The hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future.