Human Factors and Usability Engineering Director

Sanofi Group; Morristown (NJ); On-site; USD 179,000 - 258,000; Full time

Job summary

Sanofi is seeking a Director of Human Factors & Usability Engineering in Morristown, NJ, to lead global HF/UE programs spanning early user needs to Lifecycle Management across parenteral devices. This senior role partners with the Head of HF/UE to shape strategy, ensure regulatory alignment, and drive user-centered decision making.

The role requires deep expertise in HF/UE across combination products, strong regulatory interactions, and the ability to influence cross-functional teams without

Qualifications

• Bachelor’s or Master’s degree in Human Factors Engineering, Psychology, Biomedical Engineering, Industrial Design, or related field.
• 10+ years of progressive HF/UE experience across combination products and regulatory pathways.
• Proven track record delivering regulatory-compliant HF/UE solutions.
• Experience leading complex HF/UE programs with minimal oversight.
• Experience with health authority interactions (FDA, EMA, NMPA).
• Mastery of FDA HF Guidance, IEC 62366-1:2015+A1:2020, ISO 14971:2019, ISO 13485, HE75, EMA guidelines.
• Deep lifecycle HF/UE expertise across user needs to DHF/UEF documentation.
• Translate user needs into UI design decisions.
• Contribute to HF/UE regulatory submissions and health authority interactions.
• Influence cross-functional teams without formal authority.
• Mentor HF/UE professionals and build organizational capability.
• Excellent communication and stakeholder management.
• Advance HF/UE processes and standards at team/organization level.

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), 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 development priorities and 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 for scalability and standards alignment
• Influence cross-functional teams (clinical, regulatory, device, quality/risk) to embed user-centered design principles
• Mentor HF/UE professionals across the team and contribute to organizational capability
• Advance HF/UE as a strategic differentiator through thought leadership and industry standards participation

Skills

HF/UE leadership

Regulatory engagement

Stakeholder management

Mentoring

Strategy development

Cross-functional collaboration

Education

Bachelor's or Master's in HF/Eng

Job description

Human Factors & Usability Engineering Director – Morristown, NJ / Cambridge, MA

Drug Product Development & Delivery is a global business unit in Manufacturing & Supply (M&S) which develops and maintains Sanofi’s parenteral injection systems including Insulin Pens, Autoinjectors, Large Volume Devices, infusion systems, and Pre-Filled Syringes. The unit is a project‑centric organization executing early stage, development. and Lifecycle Management (LCM) projects of drug delivery devices for monoclonal antibodies (mAbs), vaccines, peptides, genomics, and more.

The Director, Human Factors & Usability Engineering is a senior individual contributor role responsible for leading complex Human Factors and Usability Engineering (HF/UE) programs across the Global Device and Packaging Unit (GDPU) portfolio. Working closely with the Head of HF/UE, this role brings deep technical expertise and organizational influence to drive product excellence, contribute to HF/UE strategy and direction, and support health authority engagements.

The Director owns significant responsibilities across the full product lifecycle from early‑stage user needs through Lifecycle Management (LCM) and is highly relied upon to lead the most complex, high‑stakes programs while advancing HF/UE as a strategic differentiator across the organization, strengthening how user‑centered thinking shapes decisions from early concept through launch. We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

About Sanofi: We’re an R&D‑driven, AI‑powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

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))
• 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
• Track record of influencing cross‑functional teams and driving 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

Salary

• The salary range for this position is: $178,500.00 - $257,833.33

Enjoy a thoughtful, well‑crafted rewards package that recognizes your contribution and amplifies your impact.

Benefits

• Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
• high‑quality healthcare
• prevention and wellness programs
• at least 14 weeks’ gender‑neutral parental leave

Why choose us?

Bring the miracles of science to life alongside a supportive, future‑focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well‑crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high‑quality healthcare, prevention and wellness programs and at least 14 weeks’ gender‑neutral parental leave. Shape the future of medicine and vaccine delivery with cutting‑edge technology, ensuring seamless launches and a resilient global supply. Power industry‑leading performance by leveraging digital, data, and AI‑driven innovation at speed and scale Transform lives worldwide by delivering life‑changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affiantive Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SA #LI-SA #vhd #LI-Hybrid Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science.

It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug‑discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.