Human Factors and Usability Engineering Director

Sanofi

. Lead complex, high-stakes HF/UE programs across the GDPU portfolio with minimal oversight .

Posted 9/18/2026full-timeMorristown • New Jersey • United StatesLead💰 $178,500 - $257,833 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Human Factors and Usability Engineering, with a proven ability to lead complex programs and deliver regulatory-compliant solutions across the full product lifecycle. Proficient in engaging with health authorities and influencing cross-functional teams to embed user-centered design principles.

Highest-signal resume keywords

Human Factors EngineeringUsability EngineeringRegulatory ComplianceHealth Authority InteractionsUser-Centered Design

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Combination Product DevelopmentUser Needs AnalysisStudy Design and ExecutionRegulatory Submission StrategyHF/UE Lifecycle ManagementKUPsURRAUEF/DHF DocumentationFDA HF Guidance MasteryIEC 62366-1:2015+A1:2020

Soft Skills

Excellent CommunicationStakeholder ManagementMentoringInfluencing Without Authority

Tools & Technologies

HF/UE MethodologiesTemplatesBest Practices

Industry Keywords

Medical DevicesSaMDDigital HealthAI/MLTherapeutic AreasRegulatory PathwaysQuality StandardsRisk Management

About the role

Key responsibilities & impact

Lead complex, high-stakes HF/UE programs across the GDPU portfolio with minimal oversight
Own deliverables across the full product lifecycle from early-stage user needs through Lifecycle Management
Drive user needs, use requirements, context of use, KUPs, URRA, generative/formative/summative study design and execution, UEF/DHF documentation, and regulatory submission strategy
Shape HF/UE vision, strategy, and roadmap with the Senior Director
Lead and support external health authority engagement and regulatory interactions across combination products, medical devices, and SaMD
Establish, harmonize, and improve HF/UE processes, methodologies, tools, and templates
Influence clinical, regulatory, device, quality, and risk teams to embed user-centered design principles
Mentor and develop HF/UE professionals
Advance HF/UE through thought leadership, industry standards contributions, and organizational best-practice development

Requirements

What you’ll need

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
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 from feasibility through Lifecycle Management
Experience leading complex, high-stakes HF/UE programs with minimal oversight
Experience supporting or leading health authority interactions with FDA, EMA, Notified Bodies, and NMPA
Mastery of FDA HF Guidance documents, IEC 62366-1:2015+A1:2020, ISO 14971:2019, ISO 13485, HE75, and EMA guidelines
Deep expertise in the full HF/UE lifecycle, including user needs, use requirements, context of use, KUPs, URRA, study design and execution, UEF/DHF documentation, and regulatory submission strategy
Ability to establish user needs, translate them into user requirements, and drive user-centric UI design decisions
Experience contributing to HF/UE regulatory submissions and health authority interactions across multiple combination product types and regulatory pathways
Ability to influence cross-functional teams in complex, matrixed organizations without formal authority
Track record of mentoring and developing HF/UE professionals
Excellent communication and stakeholder management skills
Ability to advance HF/UE processes, standards, and best practices
Preferred: expertise across multiple therapeutic areas and parenteral delivery systems
Preferred: experience spanning design, engineering, regulatory, risk management, clinical, or post-market disciplines
Preferred: experience with SaMD, digital health, and AI/ML in medical devices
Preferred: portfolio-level HF/UE strategy and cross-functional governance
Preferred: broad therapeutic area experience
Must be eligible to work in the United States or Puerto Rico, as the posting is for US and Puerto Rico residents only

Benefits

Comp & perks

Opportunities for promotion or lateral moves, at home or internationally
Thoughtful, well-crafted rewards package
Health and wellbeing benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Cutting-edge technology and digital, data, and AI-driven innovation environment