HFUE Associate Director
Sanofi
9 hours ago
Remote friendly (Swiftwater, PA)
United States
$148,500 - $214,500 USD yearly
Other
Main Responsibilities:
- Lead HF/UE strategy and execution across multiple programs and business units, ensuring rigorous, fit-for-purpose human factors engineering from early engagement through LCM.
- Drive user-centered design processes across the product portfolio, grounding user needs, use requirements, and UI design decisions in robust research and risk-based thinking.
- Shape and continuously improve HF/UE processes, methodologies, tools, and templates to advance team capabilities and align with FDA expectations and global standards.
- Lead complex generative, formative, and summative HF/UE studies (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.
- Contribute to regulatory strategy; support health authority submissions and interactions.
- Mentor and develop HF/UE team members; provide technical guidance and professional development.
- Collaborate cross-functionally with design, regulatory, clinical, quality, and marketing.
- Ensure HF/UE compliance and best practices (UEF/DHF deliverables, design controls, regulatory documentation).
- Manage and oversee external vendors/consultants supporting HF/UE study execution.
Qualifications:
- Bachelor’s in Engineering, Human factors Psychology, industrial design, Life sciences, or related field.
- 10+ years progressive experience in medical device/product human factors engineering/usability engineering/combination product human factors engineering or related.
- Mastery of relevant FDA HF guidance; IEC 62366-1:2015+A1:2020; ISO 14971:2019; ISO 13485; and EMA guidelines.
- Ability to lead/manage complex HF/UE programs across concurrent projects with minimal oversight.
- Strategic influence across cross-functional teams; track record defining/implementing HF/UE processes.
- Expertise in generative research, formative evaluation, summative validation, and use-related risk analysis.
- Excellent written/spoken English communication.
- Travel to study sites up to 20%.
Preferred Qualifications:
- Master’s degree in a related field.
- Experience across HF/UE plus related design/engineering/regulatory/risk, requirements generation, clinical practice, or post-market activities.
- Experience leading FDA submissions and regulatory interactions (FDA/EMA/Notified Bodies).
- Portfolio-level HF/UE strategy and cross-functional governance.
- Knowledge of IFU and instructional design for combination products or medical devices.
- Lead HF/UE strategy and execution across multiple programs and business units, ensuring rigorous, fit-for-purpose human factors engineering from early engagement through LCM.
- Drive user-centered design processes across the product portfolio, grounding user needs, use requirements, and UI design decisions in robust research and risk-based thinking.
- Shape and continuously improve HF/UE processes, methodologies, tools, and templates to advance team capabilities and align with FDA expectations and global standards.
- Lead complex generative, formative, and summative HF/UE studies (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.
- Contribute to regulatory strategy; support health authority submissions and interactions.
- Mentor and develop HF/UE team members; provide technical guidance and professional development.
- Collaborate cross-functionally with design, regulatory, clinical, quality, and marketing.
- Ensure HF/UE compliance and best practices (UEF/DHF deliverables, design controls, regulatory documentation).
- Manage and oversee external vendors/consultants supporting HF/UE study execution.
Qualifications:
- Bachelor’s in Engineering, Human factors Psychology, industrial design, Life sciences, or related field.
- 10+ years progressive experience in medical device/product human factors engineering/usability engineering/combination product human factors engineering or related.
- Mastery of relevant FDA HF guidance; IEC 62366-1:2015+A1:2020; ISO 14971:2019; ISO 13485; and EMA guidelines.
- Ability to lead/manage complex HF/UE programs across concurrent projects with minimal oversight.
- Strategic influence across cross-functional teams; track record defining/implementing HF/UE processes.
- Expertise in generative research, formative evaluation, summative validation, and use-related risk analysis.
- Excellent written/spoken English communication.
- Travel to study sites up to 20%.
Preferred Qualifications:
- Master’s degree in a related field.
- Experience across HF/UE plus related design/engineering/regulatory/risk, requirements generation, clinical practice, or post-market activities.
- Experience leading FDA submissions and regulatory interactions (FDA/EMA/Notified Bodies).
- Portfolio-level HF/UE strategy and cross-functional governance.
- Knowledge of IFU and instructional design for combination products or medical devices.