Human Factors Expert
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Job Summary
Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets led by VYVGART our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG and with the potential to treat patients across dozens of severe autoimmune diseases.
We are building a new kind of biotech company one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company our partnerships our science and our people because when we do we deliver more for patients.
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:
Strategize and leadhuman factors engineering activitiesthroughout thecombinationproduct development lifecycle.
Develop and executehumanfactorsstudy plans including formative and summative usability studies risk analyses and validation protocols.
Collaborate with cross-functional teams (CMCQuality Regulatory Clinical) to integrate user needs into design requirements.
Conducttask analyses user research and use-related risk assessmentstoidentifypotential use errors and mitigate risks.
Provideexpertiseondevice usability for patients with chronic conditions considering physical and cognitive limitations in consultation with medical and clinical experts.
Preparehuman factors documentationfor regulatory submissions (FDA EMA) includingHuman Factors Engineering Reports.
Ensure compliance withFDA guidance on human factorsISO 62366 and other relevant standards.
Supportdesign verification and validationactivities fordrug delivery systems such asprefilled syringes autoinjectors and other injection devices.
Stay current withindustry trends regulatory expectations and best practicesin human factors and usability engineering.
Required Experience & Skills
Proventrack recordinhuman factors/usability engineeringproject management andcross-functional leadership.
Deep understanding of human factors engineering and its application incombinationproduct development.
Familiarity with globalregulatory frameworksfor medical devices and combination products.
Strong interpersonal andcommunicationskills; ability to energize and align diverse teams.
Experience with autoinjector platforms (e.g.YpsoMate) is a plus.
Ability to work in a cross-functional global environment.
Company Values Alignment
Candidates should embodyargenxscore values: co-creation humility excellence innovation and empowerment.
#LI-Onsite
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.
At argenx all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.
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