Associate Director

Sanofi

Associate Director leading HF/UE strategy and execution for drug delivery devices at Sanofi. Overseeing user-centered design and regulatory interactions in a cross-functional leadership role.

Posted 5/26/2026full-timeMorristown • Massachusetts, New Jersey • 🇺🇸 United StatesSenior💰 $148,500 - $214,500 per yearWebsite

About the role

Key responsibilities & impact

Lead HF/UE strategy and execution across multiple programs and business units, ensuring rigorous, fit-for-purpose application of human factors engineering from early engagement through LCM
Drive user-centered design processes across the product portfolio, ensuring user needs, use requirements, and UI design decisions are grounded in robust research and risk-based thinking
Shape and continuously improve HF/UE processes, methodologies, tools, and templates to advance team capabilities and ensure alignment with current FDA expectations and global standards
Lead complex generative, formative, and summative HF/UE studies, including study design, protocol development, execution, data analysis, and reporting
Conduct and oversee use-related risk analysis (URRA), task analysis, known use problems analysis, and use-related risk control evaluation across assigned programs
Contribute to regulatory strategy and support health authority submissions and interactions
Mentor and develop HF/UE team members, providing technical guidance, professional development support, and fostering a culture of excellence and continuous learning
Collaborate cross-functionally with design, regulatory, clinical, quality, and marketing teams as a senior HF/UE leader and strategic partner
Ensure HF/UE compliance and best practices across assigned portfolio, including UEF/DHF deliverables, design controls, and regulatory documentation
Manage and oversee external vendors and consultants supporting HF/UE study execution and program delivery

Requirements

What you’ll need

Bachelor's in Engineering, Human factors Psychology, industrial design, Life sciences or related fields.
10+ years of progressive experience in medical device, product human factors engineering, usability engineering, combination product human factors engineering or any related fields.
Mastery of all relevant FDA HF Guidance documents, IEC 62366-1:2015+A1:2020, ISO 14971:2019, ISO 13485, and EMA guidelines
Proven ability to lead and manage complex HF/UE programs across multiple concurrent projects with minimal oversight
Strong strategic thinking and demonstrated ability to influence cross-functional teams and drive user-centric outcomes.
Proven track record of defining and implementing HF/UE processes, methodologies, and best practices within an organization.
Deep expertise in generative research methods, formative evaluation techniques, summative validation, and use-related risk analysis.
Excellent communication skills (written and spoken English) with demonstrated ability to present complex HF/UE concepts to diverse audiences.
Willingness to travel to study sites (up to 20%).

Benefits

Comp & perks

high-quality healthcare
prevention and wellness programs
at least 14 weeks’ gender-neutral parental leave

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

human factors engineeringusability engineeringgenerative research methodsformative evaluation techniquessummative validationuse-related risk analysisprotocol developmentdata analysisrisk-based thinkingHF/UE processes

Soft Skills

strategic thinkinginfluence cross-functional teamsmentoringtechnical guidanceprofessional developmentcommunication skillscollaborationleadershipcontinuous learningproblem-solving