Device Expert Director, Technical Operations
Job Location:
Boston, MA - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
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 coordinatecombination 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.
Roles and Responsibilities:
Cross-Functional Coordination
Act as thecentral pointof contact forcombination productdevelopment across CMC Regulatory Quality Clinical Supplies and external partners
Facilitatealignment 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
Device Development & Lifecycle Management
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
Human Factors Leadership
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
Regulatory & Quality Interface
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)
External Partner Management
Establishand maintain strong relationships with device manufacturers usability consultants and packaging suppliers
Lead contracting and oversight of service providers for device-related activities
Required Experience & Skills:
Masterdegree and 15 years of relevant experience
Proventrack recordin medical device development project management and cross-functional leadership
Deep understanding of human factors engineering and its application incombinationproduct 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
#LI-Remote
For applicants in the United States: The annual base salary hiring range for this position is $188000.00 - $258500.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective inclusive and job-related criteria such as relevant experience skills demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks.
This job is eligible to participate in our short-term and long-term incentive programs subject to the terms and conditions of those plans and applicable policies. It also includes 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.
At argenx all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.
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Required Experience:
Director
