Human Factors and Usability Engineering Director

Industrial Design; Cambridge (MA); On-site; USD 190,000 - 270,000; Full time

Benefits offered by this job

High-quality healthcare

Parental leave (14+ weeks)

Global opportunities

Job summary

Sanofi Inc. seeks a Director of Human Factors & Usability Engineering to lead HF/UE programs across the Global Device and Packaging Unit portfolio. You will guide user-centered strategies from early needs through Lifecycle Management, and oversee regulatory interactions with FDA, EMA, and other bodies.

This senior role influences decisions across development programs and company-wide HF/UE standards. You will mentor a team of HF/UE professionals, align HF/UE plans with product priorities, and

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 experience in combination product development across multiple therapeutic areas and regulatory pathways.
• Proven track record of delivering regulatory-compliant HF/UE solutions for combination products across lifecycle stages.

Responsibilities

• Lead complex, high-stakes HF/UE programs across the GDPU portfolio with minimal oversight.
• Drive the full HF/UE lifecycle from user needs to LCM, URRA, and DHF/UEF documentation.
• Shape HF/UE vision, strategy, and roadmap in partnership with senior leadership.
• Lead external health authority engagements (FDA, EMA, Notified Bodies, NMPA) across combination products.
• Establish and continuously improve HF/UE processes, tools, and templates.
• Mentor HF/UE professionals and contribute to organizational capability.
• Advance HF/UE as a strategic differentiator through industry standards and best practices.

Skills

HF/UE expertise

Regulatory engagement

Cross-functional influence

Stakeholder management

Education

Bachelor's or Master's in HF Eng, Psychology, Biomed Eng, Industrial Design, or related

Tools

UEF/DHF documentation

URRA methodology

HF/UE regulations

Job description

Job Title: Human Factors & Usability Engineering Director

• Location: Morristown, NJ or Cambridge, MA

About the Job

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 whileadvancing 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)

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

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 andwellness 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 Affir…

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 be found here.