Device Expert Director, Technical Operations
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. Purpose of the Role: To lead and coordinate combination product-related activities across functional teams and projects, ensuring robust design, development, and usability of drug delivery systems, with a strong emphasis on human factors integration and regulatory readiness. Key: bring everything together.
Requirements
- Master degree and 15+ years of relevant experience
- Proven track record in medical device development, 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 leadership
- Strong interpersonal and communication skills; ability to energize and align diverse teams
Nice To Haves
- Experience with autoinjector platforms (e.g., YpsoMate) is a plus
Responsibilities
- Act as the central point of contact for combination product development across CMC, Regulatory, Quality, Clinical Supplies, and external partners
- Facilitate alignment of device strategy across multiple programs, ensuring consistency and scalability
- Lead regular device team meetings and ensure transparent communication of project status, risks, and milestones
- Oversee design, industrialization, and lifecycle management of combination products including prefilled syringes and auto-injectors
- Drive design control activities including design input/output, verification, validation, and risk management
- Coordinate formative and summative human factors studies in collaboration with internal teams and external providers
- Ensure integration of usability engineering into design and risk management processes
- Review and interpret human factors data to inform design decisions and regulatory submissions
- Contribute to regulatory submissions including authoring and reviewing device sections
- Ensure compliance with applicable standards (ISO 13485, ISO 14971, EU MDR, 21 CFR Part 820)
- Establish and maintain strong relationships with device manufacturers, usability consultants, and packaging suppliers
- Lead contracting and oversight of service providers for device-related activities
Benefits
- retirement savings plans
- health benefits
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What This Job Offers
Job Type
Full-time
Career Level
Director
