[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.ResponsibilitiesAct as the central point of contact for combination product development across CMC, Regulatory, Quality, Clinical Supplies, and external partnersFacilitate alignment of device strategy across multiple programs, ensuring consistency and scalabilityLead regular device team meetings and ensure transparent communication of project status, risks, and milestonesOversee design, industrialization, and lifecycle management of combination products including prefilled syringes and auto-injectorsDrive design control activities including design input/output, verification, validation, and risk managementCoordinate formative and summative human factors studies in collaboration with internal teams and external providersEnsure integration of usability engineering into design and risk management processesReview and interpret human factors data to inform design decisions and regulatory submissionsContribute to regulatory submissions including authoring and reviewing device sectionsEnsure 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 suppliersLead contracting and oversight of service providers for device-related activitiesSkillsMaster degree and 15+ years of relevant experienceProven track record in medical device development, project management, and cross-functional leadershipDeep understanding of human factors engineering and its application in combination product developmentFamiliarity with global regulatory frameworks for medical devices and combination productsStrong leadershipStrong interpersonal and communication skills; ability to energize and align diverse teamsExperience with autoinjector platforms (e.g., YpsoMate) is a plus25% travelBenefitsShort-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policiesA 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 guidelinesCompany Overviewargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. It was founded in 2008, and is headquartered in Boston, Massachusetts, USA, with a workforce of 1001-5000 employees. Its website is https://www.argenx.com/.Company H1B Sponsorshipargenx has a track record of offering H1B sponsorships, with 1 in 2026, 4 in 2025, 5 in 2023, 4 in 2022, 3 in 2021. Please note that this does not guarantee sponsorship for this specific role.