Fabrication et Approvisionnement
Là où les miracles
de la science
deviennent une réalité pour les patients
Senior, Human Factors and Usability Engineer
Morristown, New Jersey Salary Range USD 122,250.00 - 176,583.33
En bref
Nos équipes produisent et livrent chaque année plus de 4 milliards de médicaments et de vaccins, veillant à ce que chaque avancée soit accessible à ceux qui en ont le plus besoin. Grâce à des infrastructures ultra-modernes, des usines intelligentes pilotées par l’IA et une automatisation de pointe, nous repoussons les limites pour garantir que nos traitements parviennent aux patients plus rapidement, en toute sécurité et de manière plus durable que jamais. C’est ici que votre expertise, votre ambition et votre passion peuvent façonner l’avenir de la santé.
Job Title: Senior, Human Factors and Usability Engineer
Location: Cambridge, MA, Morristown, NJ
About the Job
Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.
GDPU is a global business unit in M&S which develops and maintains Sanofi's parenteral injection systems like Insulin Pens, Autoinjectors, Large Volume Devices, infusion systems and Pre-Filled Syringes. The unit is a project-centric organization executing development and LCM projects of drug delivery devices for mAbs, vaccines, peptides, genomics etc. and supports device product maintenance post launch.
The Senior Human Factors & Usability Engineer will execute and support GDPU HF/UE activities from early engagement through LCM. Responsibilities include contributing to submission strategies and planning, conducting user needs analysis, supporting user requirements development, performing task analysis, conducting use-related risk analysis, supporting user interface (UI) design, and executing formative and summative validation studies. You will contribute to expanding HF/UE knowledge and may participate in international standards organizations like AAMI, ISO, DIN, AFNOR to support knowledge sharing and standard development.
You will build and apply your knowledge and network in industry, at patient associations and with regulators to support our product pipeline and related technology innovation strategy. You will serve as a key contributor to regulatory and association interactions outside Sanofi.
Usability engineering includes supporting the development of User Needs and User Requirements as well as analyzing user feedback from studies, patient associations and open sources like literature, internet and other sources.
Our team will support our mission to make the impossible possible by better informing the user-interface design of our products, ensuring they are safe and effective for use, improving overall usability, reducing use-related errors, while providing best-in-class and first-in-class products.
Working together to define user needs and establish user requirements that meet the unmet needs of patients.
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 people’s lives.
Main Responsibilities:
The Senior Human Factors & Usability Engineer will provide subject matter expertise to support strategy, planning, and execution of fit-for-purpose HF/UE activities for programs across the Sanofi portfolio from early engagement through LCM.
Applying generative, formative and summative research methods under guidance and independently for routine studies.
Supporting HFE strategies and executing HF activities on drug delivery device technology development and/or drug-device combination product program teams from early-stage development to new product introduction and support for on-market products.
In this role you will contribute to advancing HF/UE processes, procedures, tools and methods with the goal of maximizing the value of HF involvement.
Additional Responsibilities:
Support usability engineering and Human Factors compliance with authority expectations and contribute to regulatory interactions (AAMI, ISO, IEC) as well as authorities (FDA, EMEA, CFDA) under the direction of the Head of HF/UE.
Ensure all devices and related materials like packaging, co-packed components, Instructions for Use and related training materials incorporate usability engineering principles for optimal usability and regulatory compliance.
Support program strategies and contribute to identifying potential risks and developing actionable strategies aligned with industry best practices and health authority expectations.
Work with internal and external resources to support agility and ensure fit-for-purpose capabilities, contributing to expanding collective HF expertise.
*Your expertise in human factors engineering, usability, and user-centered design principles will contribute to ensuring the safe and effective use of medical devices and drug device combination products (such as Autoinjectors, Safety-Syringes, Pens etc.) by healthcare professionals and patients.
About You
Required Skills:
Bachelor’s or master’s degree in Human Factors Engineering, Biomedical Engineering, Biomechanics, Mechanical Engineering, HF Behavioral Sciences, Psychology, Industrial Design, or related field.
Extensive experience in the pharmaceutical or medical device industry.
Strong knowledge and practical application of human factors engineering, design controls, and risk management standards and guidances (e.g., IEC 62366, FDA HF Guidance, ISO 14971) across end‑to‑end combination product development.
Demonstrated analytical thinking, problem‑solving, and research design skills; ability to analyze data with proficiency in basic statistics.
Experience planning and executing ethnographic, formative, and summative usability studies, with or without external vendors.
Ability to translate study insights and technical constraints into clear user needs and actionable design recommendations.
Strong cross‑functional collaboration and interpersonal skills.
Ability to work independently with appropriate guidance and oversight.
Preferred:
Experience in package design and development of safety‑critical information to support product use and user interface design.
Experience creating instructional materials and patient support programs for new product introductions and on‑market support.
Working knowledge of periodic risk reviews and change control processes for on‑market drug‑device combination products.
Experience with health authority submissions and interactions (e.g., FDA, EMA, Notified Bodies).
Understanding of drug‑device development and the integration of HF/UE with market research, risk management, design controls, and lifecycle management processes.
Expertise in human factors engineering, usability engineering, and user‑centered design principles for medical devices and combination products.
Ability to adapt to a rapidly changing environment.
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.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative 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.
#GD-SA
#LI-SA
#LI-Onsite
#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.
Toujours Progresser. Découvrir l’Extraordinaire.
Rejoignez Sanofi et entrez dans une nouvelle ère de la science – où votre parcours peut être aussi transformateur que le travail que nous accomplissons. Nous investissons en vous pour que vous alliez plus loin, accélériez votre réflexion et accomplissiez ce qui n’a jamais été fait auparavant. Vous contribuerez à repousser les limites, à bousculer les conventions et à concevoir des solutions plus intelligentes pour les communautés que nous servons. Prêt·e à poursuivre les miracles de la science et à améliorer la vie des gens ? Poursuivons le progrès et découvrons l’extraordinaire – ensemble.
Chez Sanofi, nous croyons dans l’égalité des chances, sans distinction de race, de couleur, d’ascendance, de religion, de sexe, d’origine, d’orientation sexuelle, d’âge, de citoyenneté, d’état civil, de handicap, d’identité de genre ou de tout autre critère protégé par la loi.
En savoir plus
sur ce site
Pourquoi nous rejoindre ?
- Nous ne faisons pas que fabriquer des médicaments—nous créons un impact. Grâce à notre réseau international d’installations de pointe, nous veillons à ce que les patients reçoivent les traitements dont ils ont besoin, au moment où ils en ont besoin.
- L’innovation est notre moteur. De la fabrication pilotée par l’IA aux méthodes de production inédites, nous repoussons les limites de l’efficacité et de la performance.
- Ici, vous évoluez. Que ce soit en production, en qualité, en ingénierie ou en supply chain, vous collaborerez avec des experts de renom, développerez vos compétences et contribuerez à façonner l’avenir de l’industrie pharmaceutique.
- Nous faisons ce qui est juste. Sécurité, durabilité, diversité, équité et inclusion sont au cœur de notre engagement, garantissant un environnement où chacun peut s’épanouir.
Tous engagés pour la diversité
Chez Sanofi, la diversité des perspectives est une source d’innovation au service des patients. Découvrez Hamza Laajaj, Chef de projet déploiement applicatif à Neuville-sur-Saône, et son engagement pour un environnement inclusif où chaque voix compte. Pour lui, c’est en embrassant la diversité que nous libérons l’innovation et repoussons les limites de la santé.
"Nous faisons ce qui est juste. Sécurité, développement durable, diversité, équité et inclusion sont au cœur de notre engagement, garantissant un environnement où chacun peut s’épanouir."
Brendan O’Callaghan
Executive Vice President of Manufacturing and Supply
En savoir plus
Carrière dans la Fabrication et l’Approvisionnement
Découvrez comment Sanofi révolutionne la production pharmaceutique et les chaînes d’approvisionnement grâce aux technologies de pointe, à l’innovation digitale et à des pratiques durables. Rejoignez-nous pour contribuer à la distribution efficace et responsable de médicaments essentiels.
Accélérer l’innovation biopharma avec McLaren Racing
Qu’ont en commun la Formule 1 et la biopharma ? La vitesse, la précision et l’excellence. Découvrez comment Sanofi et McLaren Racing repoussent les limites du développement de médicaments grâce aux sciences de la performance de pointe.
Rejoignez notre communauté
de talents
Que pourrions-nous accomplir ensemble ? Chaque Sanofien travaille sur des projets qui ont un véritable impact sur la vie des gens.
Inscrivez-vous dès aujourd'hui et découvrez nos dernières opportunités dès qu'elles seront disponibles.