Human Factors and Usability Engineering Director (Medical Devices)

Location: Morristown, NJ or Cambridge, MA; hybrid role. US and Puerto Rico residents only.

Salary: $178,500–$257,833 per year

Company

hirify.global is an R&D-driven biopharmaceutical company developing medicines, vaccines, and drug delivery technologies.

What you will do

• Lead complex Human Factors and Usability Engineering programs across drug-device combination products and the full product lifecycle.
• Define user needs, use requirements, context of use, known use problems, and use-related risk analyses.
• Design and execute generative, formative, and summative usability studies and maintain UEF/DHF documentation.
• Support regulatory submissions and health authority interactions with the FDA, EMA, Notified Bodies, and NMPA.
• Establish and improve HF/UE processes, methodologies, tools, templates, and organizational standards.
• Influence clinical, regulatory, device, quality, and risk teams while mentoring HF/UE professionals.

Requirements

• Bachelor’s or Master’s degree in Human Factors Engineering, Psychology, Biomedical Engineering, Industrial Design, or a related field.
• 10+ years of progressive Human Factors and Usability Engineering experience, including drug-device combination products.
• Experience leading complex, high-stakes programs with minimal oversight from feasibility through Lifecycle Management.
• Mastery of FDA Human Factors Guidance, IEC 62366-1, ISO 14971, ISO 13485, HE75, and EMA guidelines.
• Experience with usability study design and execution, user-centered requirements, regulatory submissions, and health authority interactions.
• Ability to influence matrixed cross-functional organizations and mentor HF/UE professionals.

Nice to have

• Experience with parenteral delivery systems such as autoinjectors, prefilled syringes, pens, or large-volume devices.
• Experience across design, engineering, quality, regulatory, risk management, clinical practice, or post-market activities.
• Experience with SaMD, digital health, and AI/ML in medical devices.
• Portfolio-level HF/UE strategy experience and therapeutic area knowledge spanning mAbs, vaccines, peptides, genomics, or small molecules.

Culture & Benefits

• Supportive, future-focused environment centered on science, healthcare innovation, and patient outcomes.
• Opportunities for career growth through promotion or lateral moves, including international opportunities.
• Healthcare, wellness, and prevention programs with at least 14 weeks of gender-neutral parental leave.
• Opportunity to shape medicine and vaccine delivery through digital, data, and AI-driven innovation.