Job Title: Human Factors & Usability Engineering Director

• Location: Morristown, NJ or Cambridge, MA

Main Responsibilities

• Lead complex, high-stakes HF/UE programs across the GDPU portfolio with minimal oversight, owning deliverables across the full product lifecycle from early-stage user needs through LCM

• Drive the full HF/UE lifecycle hands-on: user needs, use requirements, context of use, Known Use Problems (KUPs), Use-Related Risk Analysis (URRA), generative/formative/summative study design and execution, UEF/DHF documentation, and regulatory submission strategy

• Shape and advance HF/UE vision, strategy, and roadmap in partnership with the Senior Director, ensuring alignment with product development priorities and evolving global regulatory expectations

• Lead and support external health authority engagement and regulatory interactions (FDA, EMA, Notified Bodies, NMPA) across combination products, medical devices, and SaMD

• Establish, harmonize, and continuously improve HF/UE processes, methodologies, tools, and templates to ensure scalability, consistency, and alignment with current FDA, EMA, and international standards

• Influence cross-functional teams (clinical, regulatory, device, quality/risk) to embed user-centered design principles throughout product development without formal authority

• Mentor and develop HF/UE professionals across the team, contributing to organizational capability, scientific rigor, and a culture of continuous improvement

• Advance HF/UE as a strategic differentiator through thought leadership, contribution to industry standards (AAMI, ISO, IEC), and best practice development at the organizational level

About You

Basic Qualifications

• Bachelor's or Master's degree in Human Factors Engineering, Psychology, Biomedical Engineering, Industrial Design, or related field

• 10+ years of progressive experience in Human Factors and Usability Engineering with deep, demonstrated experience in combination product development including drug-device combination products across multiple therapeutic areas and regulatory pathways

• Proven track record of delivering regulatory-compliant HF/UE solutions for combination products, spanning feasibility through Lifecycle Management (LCM)

• Demonstrated experience leading complex, high-stakes HF/UE programs with minimal oversight

• Experience supporting or leading health authority interactions (Food and Drug Administration (FDA), European Medicines Agency (EMA), Notified Bodies, National Medical Products Administration (NMPA)

Technical Expertise:

• Mastery of FDA HF Guidance documents, International Electrotechnical Commission (IEC) 62366-1:2015+A1:2020, International Organization for Standardization (ISO) 14971:2019, ISO 13485, HE75, and EMA guidelines

• Deep expertise in the full HF/UE lifecycle: user needs, use requirements, context of use, Known Use Problems (KUPs), Use-Related Risk Analysis (URRA), generative/formative/summative study design and execution, Usability Engineering File (UEF)/Design History File (DHF) documentation, and regulatory submission strategy

• Proven ability to establish user needs, translate them into user requirements, and drive user-centric User Interface (UI) design decisions

• Experience contributing to HF/UE regulatory submissions and health authority interactions across multiple combination product types and regulatory pathways

Leadership & Organizational Impact:

• Demonstrated ability to influence cross-functional teams and drive HF/UE integration across complex, matrixed organizations without formal authority

• Track record of mentoring and developing HF/UE professionals and contributing to organizational capability

• Excellent communication and stakeholder management skills

• Proven ability to contribute to and advance HF/UE processes, standards, and best practices at a team or organizational level

Preferred Qualifications:

• Proven expertise in combination product Human Factors and Usability Engineering across multiple therapeutic areas including experience with parenteral delivery systems such as autoinjectors, prefilled syringes, pens, or large volume devices

• Professional experience beyond HF/UE spanning design disciplines (user-centric, industrial, Instructions for Use (IFU), graphic), engineering fields (device, systems, quality), regulatory and risk management, requirements generation, clinical practice, or post-market activities considered a meaningful differentiator

• Experience with emerging technologies including Software as a Medical Device (SaMD), digital health, and AI/ML in medical devices

• Track record of advancing HF/UE practices and methodologies within organizations

• Experience with portfolio-level HF/UE strategy and cross-functional governance

• Broad therapeutic area experience spanning monoclonal antibodies (mAbs), vaccines, peptides, genomics, and/or small molecules

The salary range for this position is:

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can