HF/UE Associate Director - Lead Usability Strategy

Sanofi Group; Morristown (NJ); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Healthcare benefits

Parental leave (14+ weeks)

Career development & mentoring

Job summary

Sanofi Inc. is seeking an HFUE Associate Director to lead human factors and usability engineering across a broad portfolio of drug delivery devices and combination products.

You will guide strategy, oversee studies, and ensure alignment with regulatory expectations, while mentoring the HF/UE team and shaping cross-functional processes. You will collaborate with design, regulatory, clinical, quality, and marketing groups to deliver risk-based, user-centered solutions and drive lifecycle

Qualifications

• Bachelor's degree in engineering, HF psychology, industrial design, life sciences or related field.
• 10+ years progressive experience in medical device/human factors engineering/usability engineering.
• Mastery of FDA HF Guidance, 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 cross-functional influence to drive user-centric outcomes.
• Proven track record of defining and implementing HF/UE processes and best practices.
• Deep expertise in generative, formative, summative HF/UE studies and URRA.
• Excellent written/spoken English; travel up to 20%.

Responsibilities

• Lead HF/UE strategy and execution across multiple programs, ensuring fit-for-purpose human factors engineering.
• Drive user-centered design across the product portfolio grounded in robust research and risk-based thinking.
• Shape HF/UE processes, tools, and templates to align with FDA expectations and global standards.
• Lead generative, formative, and summative HF/UE studies from design to reporting.
• Oversee URRA, task analysis, known use problems, and use-related risk control evaluation.
• Contribute to regulatory strategy and support health authority submissions.
• Mentor HF/UE team members and foster continuous learning.
• Collaborate cross-functionally with design, regulatory, clinical, quality, and marketing.

Skills

Engineering

Human factors

Industrial design

Life sciences

Regulatory knowledge

Communication

Travel willingness

Education

Bachelor's degree in Engineering, HF Psychology, industrial design, Life sciences or related fields

Master's degree

Job description

Sanofi Inc. is seeking an HFUE Associate Director to lead human factors and usability engineering across a broad portfolio of drug delivery devices and combination products.

You will guide strategy, oversee studies, and ensure alignment with regulatory expectations, while mentoring the HF/UE team and shaping cross-functional processes. You will collaborate with design, regulatory, clinical, quality, and marketing groups to deliver risk-based, user-centered solutions and drive lifecycle