Senior, Human Factors and Usability Engineer

Senior Human Factors and Usability Engineer

Location: Cambridge, MA & Morristown, NJ

Join a global network that powers how Sanofi delivers life‑changing treatments faster and  Manufacturing & Supply, you’ll help reimagine how patients reach life‑changing treatments worldwide.

GDPU is a global business unit that develops and maintains Sanofi’s parenteral injection systems such as Insulin Pens, Autoinjectors, Large Volume Devices, infusion systems and Pre‑Filled Syringes. The unit is project‑centric, executing development and lifecycle‑management projects of drug delivery devices for mAbs, vaccines, peptides, genomics and supports product maintenance post‑launch.

The Senior Human Factors & Usability Engineer will execute and support GDPU HF/UE activities from early engagement through lifecycle management. 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 such as 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 such as 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.

• 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 lifecycle management.
• Apply generative, formative and summative research methods under guidance and independently for routine studies.
• Support HFE strategies and execute 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.
• Contribute to advancing HF/UE processes, procedures, tools and methods with the goal of maximizing the value of HF involvement.

• 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 such as 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.
• Ensure 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.

• 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…