Senior, Human Factors and Usability Engineer
Scorpion Therapeutics, Convent Station, New Jersey, us, 07961
Role Summary
Senior, Human Factors & Usability Engineer for GDPU within Sanofi's Manufacturing & Supply. Location: Cambridge, MA; Morristown, NJ. Lead human factors/usability activities from early engagement through lifecycle management, contribute to user needs, requirements, UI design, and use-related risk analyses, and support regulatory interactions. Collaborate with cross-functional teams and regulators to ensure safe and effective drug-device delivery systems. 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. 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. Qualifications
Required: Extensive experience in the pharmaceutical or medical device industry. Required: 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. Required: Demonstrated analytical thinking, problem-solving, and research design skills; ability to analyze data with proficiency in basic statistics. Required: Experience planning and executing ethnographic, formative, and summative usability studies, with or without external vendors. Required: Ability to translate study insights and technical constraints into clear user needs and actionable design recommendations. Required: Strong cross-functional collaboration and interpersonal skills. Required: 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. Preferred: Experience creating instructional materials and patient support programs for new product introductions and on-market support. Preferred: Working knowledge of periodic risk reviews and change control processes for on-market drug-device combination products. Preferred: Experience with health authority submissions and interactions (e.g., FDA, EMA, Notified Bodies). Preferred: Understanding of drug-device development and the integration of HF/UE with market research, risk management, design controls, and lifecycle management processes. Preferred: Expertise in human factors engineering, usability engineering, and user-centered design principles for medical devices and combination products. Preferred: Ability to adapt to a rapidly changing environment. Education
Bachelor’s or master’s degree in Human Factors Engineering, Biomedical Engineering, Biomechanics, Mechanical Engineering, HF Behavioral Sciences, Psychology, Industrial Design, or related field.
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Senior, Human Factors & Usability Engineer for GDPU within Sanofi's Manufacturing & Supply. Location: Cambridge, MA; Morristown, NJ. Lead human factors/usability activities from early engagement through lifecycle management, contribute to user needs, requirements, UI design, and use-related risk analyses, and support regulatory interactions. Collaborate with cross-functional teams and regulators to ensure safe and effective drug-device delivery systems. 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. 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. Qualifications
Required: Extensive experience in the pharmaceutical or medical device industry. Required: 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. Required: Demonstrated analytical thinking, problem-solving, and research design skills; ability to analyze data with proficiency in basic statistics. Required: Experience planning and executing ethnographic, formative, and summative usability studies, with or without external vendors. Required: Ability to translate study insights and technical constraints into clear user needs and actionable design recommendations. Required: Strong cross-functional collaboration and interpersonal skills. Required: 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. Preferred: Experience creating instructional materials and patient support programs for new product introductions and on-market support. Preferred: Working knowledge of periodic risk reviews and change control processes for on-market drug-device combination products. Preferred: Experience with health authority submissions and interactions (e.g., FDA, EMA, Notified Bodies). Preferred: Understanding of drug-device development and the integration of HF/UE with market research, risk management, design controls, and lifecycle management processes. Preferred: Expertise in human factors engineering, usability engineering, and user-centered design principles for medical devices and combination products. Preferred: Ability to adapt to a rapidly changing environment. Education
Bachelor’s or master’s degree in Human Factors Engineering, Biomedical Engineering, Biomechanics, Mechanical Engineering, HF Behavioral Sciences, Psychology, Industrial Design, or related field.
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