Sanofi
Healthcare
HFUEAssociateDirector
“HFUE Associate Director at Sanofi. Skills: Human Factors Engineering, Usability Engineering, Regulatory Strategy, Team Leadership. Lead HF/UE strategy and execution. Drive user-centered design processes”
What You'll Achieve.
Ensure product safety and effectiveness; Drive user-centric design; Advance team capabilities; Ensure alignment with current FDA expectations and global standards; Drive user-centric outcomes
Industry & Context.
Risk-based thinking; Use-related risk analysis
Willingness to travel to study sites (up to 20%)
What They're Looking For.
Must Have
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, 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
Nice to Have
Masters degreein Engineering, Human factors Psychology, industrial design, Life sciences or related fields, Professional experience beyond HF/UE spanning design disciplines (user-centric, industrial, IFU, graphic), engineering fields (device, systems, quality), regulatory and risk management, requirements generation, clinical practice, or post-market activities is highly valued, considered a meaningful differentiator, and strengthens cross-functional influence and HF/UE strategy, Experience leading FDA submissions and regulatory interactions (FDA, EMA, Notified Bodies), Experience with portfolio-level HF/UE strategy and cross-functional governance, Knowledge of IFU & instructional design for combination products or medical devices
What You'll Do.
Lead HF/UE strategy and execution
Drive user-centered design processes
Shape and improve HF/UE processes
and summative HF/UE studies
Conduct and oversee use-related risk analysis
Contribute to regulatory strategy
Mentor and develop HF/UE team members
Collaborate cross-functionally
Ensure HF/UE compliance and best practices
Manage and oversee external vendors
How You'll Work.
Team & Collaboration
Collaborate cross-functionally with design, regulatory, clinical, quality, and marketing teams; Influence cross-functional teams
Communication Scope
Excellent communication skills (written and spoken English); Present complex HF/UE concepts to diverse audiences
Process & Methodology
Lead complex HF/UE programs, Manage multiple concurrent projects
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