Human Factors and Usability Engineering Director

BioSpace; Morristown (NJ); On-site; USD 180,000 - 230,000; Full time

Job summary

Sanofi Inc. is seeking a Director of Human Factors & Usability Engineering in Morristown, NJ (with Cambridge, MA option).

You will lead complex HF/UE programs across the Global Device and Packaging Unit, shaping strategy and aligning with regulatory expectations to deliver user-centered medical device and combination product solutions. You will drive the HF/UE lifecycle from needs through LCM, engage with health authorities worldwide, and mentor teams while advancing industry standards and best

Qualifications

• Bachelor’s or Master’s degree in Human Factors Engineering, Psychology, Biomedical Engineering, Industrial Design, or related field.
• 10+ years of HF/UE experience in combination product development across 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).

Responsibilities

• Lead high-stakes HF/UE programs across the GDPU portfolio from early-stage user needs to Lifecycle Management.
• Oversee complete HF/UE lifecycle: needs, requirements, URRA, KUPs, study design, DHF/UEF, regulatory strategy.
• Shape HF/UE vision and roadmap aligned with product priorities and regulatory expectations.
• Engage with health authorities and regulatory bodies across device and SaMD products.
• Harmonize HF/UE processes, tools, and templates to ensure scalability and standard compliance.
• Influence cross-functional teams to embed user-centered design without formal authority.
• Mentor HF/UE professionals and build organizational capability.
• Advance HF/UE practice to differentiate products and contribute to industry standards.

Skills

HF/UE leadership

Regulatory interactions

Stakeholder management

Cross-functional influence

Mentoring HF/UE

Education

Bachelor’s or Master’s in Human Factors/related field

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.

About Sanofi

Were an R&D-driven, AI-powered biopharma company committed to improving peoples 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 its 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 Aff…

#GD-SA #vhd 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.