Device Expert Director – Technical Operations

argenx

Device Expert leading combination product development at argenx, focusing on drug delivery systems and human factors engineering. Collaborating across multiple departments to innovate and ensure regulatory compliance.

Posted 6/16/2026full-timeBoston • Massachusetts • 🇺🇸 United StatesLead💰 $188,000 - $258,500 per yearWebsite

About the role

Key responsibilities & impact

Lead and coordinate combination product-related activities across functional teams and projects
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
Oversee design, industrialization, and lifecycle management of combination products including prefilled syringes and auto-injectors
Coordinate formative and summative human factors studies in collaboration with internal teams and external providers
Contribute to regulatory submissions including authoring and reviewing device sections

Requirements

What you’ll need

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
Experience with autoinjector platforms (e.g., YpsoMate) is a plus
Strong interpersonal and communication skills; ability to energize and align diverse teams

Benefits

Comp & perks

comprehensive benefits package
retirement savings plans
health benefits

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

medical device developmentproject managementhuman factors engineeringcombination product developmentregulatory submissionsdesign managementindustrializationlifecycle managementautoinjector platformsformative and summative studies

Soft Skills

interpersonal skillscommunication skillscross-functional leadershipteam alignmentcollaborationcoordinationstrategic thinkingproblem-solvinginfluencingenergizing teams

Certifications

Master's degree