[Remote] Device Expert Director, Technical Operations

Note: The job is a remote job and is open to candidates in USA. argenx is a biotech company transforming immunology and delivering medicines for autoimmune patients. The Device Expert Director will lead and coordinate combination product-related activities across functional teams, ensuring robust design and regulatory readiness of drug delivery systems.

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

Skills

• 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
• Experience with autoinjector platforms (e.g., YpsoMate) is a plus
• 25% travel

Benefits

• Short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies
• A comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines

Company Overview

Company H1B Sponsorship