Human Factors Expert

argenx • Boston, MA

4d • Onsite

About The Position

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 are seeking a highly skilled Human Factors Expert to join our team in the development of drug/device combination products. The ideal candidate will have extensive experience in human factors engineering (HFE) and usability studies for prefilled 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.

Requirements

• Proven track record in human factors/usability engineering, project management, and cross-functional leadership.
• Deep understanding of human factors engineering and its application in combination product development.
• Familiarity with global regulatory frameworks for medical devices and combination products.
• Strong interpersonal and communication skills; ability to energize and align diverse teams.
• Ability to work in a cross-functional, global environment.
• Candidates should embody argenx’s core values: co-creation, humility, excellence, innovation, and empowerment.

Nice To Haves

• Experience with autoinjector platforms (e.g., YpsoMate) is a plus.

Responsibilities

• Strategize and lead human factors engineering activities throughout the combination product development lifecycle.
• Develop and execute human factors study plans, including formative and summative usability studies, risk analyses, and validation protocols.
• Collaborate with cross-functional teams (CMC, Quality, Regulatory, Clinical) to integrate user needs into design requirements.
• Conduct task analyses, user research, and use-related risk assessments to identify potential use errors and mitigate risks.
• Provide expertise on device usability for patients with chronic conditions, considering physical and cognitive limitations, in consultation with medical and clinical experts.
• Prepare human factors documentation for regulatory submissions (FDA, EMA), including Human Factors Engineering Reports.
• Ensure compliance with FDA guidance on human factors, ISO 62366, and other relevant standards.
• Support design verification and validation activities for drug delivery systems such as prefilled syringes, autoinjectors, and other injection devices.
• Stay current with industry trends, regulatory expectations, and best practices in human factors and usability engineering.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed