Human Factors Expert

Responsibilities

• Strategize and lead human factors engineering (HFE) 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 and mitigate potential use errors.
• Provide expertise on device usability for patients with chronic conditions, considering physical and cognitive limitations.
• Prepare human factors documentation and engineering reports for regulatory submissions to the FDA and EMA.
• Ensure compliance with FDA guidance, ISO 62366, and other relevant global standards.
• Support design verification and validation for drug delivery systems such as prefilled syringes and autoinjectors.

Requirements

• Proven track record in human factors/usability engineering and combination product development.
• Extensive experience in project management and cross-functional leadership.
• Deep understanding of global regulatory frameworks for medical devices and combination products.
• Strong interpersonal and communication skills with the ability to align diverse, global teams.
• Experience with autoinjector platforms (e.g., YpsoMate) is a plus.

About the Company

argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, we are accelerating progress toward our bold 2030 vision to transform the landscape of autoimmune treatment. We maintain our roots as a science-based start-up while pushing the boundaries of innovation to deliver more for patients.