HFUE Associate Director

Sanofi • Cambridge, MA

3d • $148,500 - $214,500

About The Position

The HFUE Associate Director leads human factors and usability engineering strategy and execution across multiple programs and business units, driving user-centered design and supporting product safety and effectiveness across Sanofi’s portfolio. The role combines technical expertise with strategic leadership, including shaping team processes, mentoring HF/UE professionals, and contributing to regulatory strategy and external engagement under the direction of the Director and Global Head of HF/UE.

The position oversees HF/UE work across drug delivery devices and combination products, from early-stage generative research through summative validation and lifecycle management. It drives cross-functional integration, develops team methodologies and tools, supports regulatory strategy and health authority interactions, and leads complex programs while influencing organizational direction and developing HF/UE talent.

Requirements

• Bachelor’s degree in engineering, human factors psychology, industrial design, life sciences, or a related field.
• 10+ years of progressive experience in medical device, product human factors engineering, usability engineering, combination product human factors engineering, or a related field.
• Mastery of relevant FDA HF guidance documents, IEC 62366-1:2015+A1:2020, ISO 14971:2019, ISO 13485, and EMA guidelines.
• Ability to lead and manage complex HF/UE programs across multiple concurrent projects with minimal oversight.
• Strong strategic thinking and ability to influence cross-functional teams and drive user-centric outcomes.
• Track record of defining and implementing HF/UE processes, methodologies, and organizational best practices.
• Expertise in generative research methods, formative evaluation techniques, summative validation, and use-related risk analysis.
• Excellent written and spoken English communication skills, including the ability to present complex HF/UE concepts to diverse audiences.
• Willingness to travel to study sites up to 20%.

Nice To Haves

• Master’s degree in engineering, human factors psychology, industrial design, life sciences, or a related field.
• Experience beyond HF/UE in design disciplines such as user-centric, industrial, IFU, or graphic design; engineering fields such as device, systems, or quality; regulatory and risk management; requirements generation; clinical practice; or post-market activities.
• Experience leading FDA submissions and regulatory interactions with FDA, EMA, or Notified Bodies.
• Experience with portfolio-level HF/UE strategy and cross-functional governance.
• Knowledge of IFU and instructional design for combination products or medical devices.

Responsibilities

• Lead HF/UE strategy and execution across programs and business units, from early engagement through lifecycle management.
• Drive user-centered design processes and ensure user needs, use requirements, and user-interface design decisions are grounded in research and risk-based thinking.
• Shape and improve HF/UE processes, methodologies, tools, and templates in alignment with FDA expectations and global standards.
• Lead 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 evaluation of use-related risk controls.
• Contribute to regulatory strategy and support health authority submissions and interactions.
• Mentor and develop HF/UE team members through technical guidance and professional development support.
• Collaborate 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 the assigned portfolio, including UEF/DHF deliverables, design controls, and regulatory documentation.
• Manage external vendors and consultants supporting HF/UE study execution and program delivery.

Benefits

• Health and wellbeing benefits, including high-quality healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Rewards package recognizing employee contributions.
• Employees may be eligible to participate in company employee benefit programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Director