HFUE Associate Director
Sanofi
12 days ago
Remote friendly (Cambridge, MA)
United States
$148,500 - $214,500 USD yearly
Other
Main Responsibilities
- Lead HF/UE strategy and execution across multiple programs and business units, applying human factors engineering from early engagement through LCM.
- Drive user-centered design across the portfolio, grounding user needs, use requirements, and UI decisions in robust research and risk-based thinking.
- Shape and continuously improve HF/UE processes, methodologies, tools, and templates aligned with FDA expectations and global standards.
- Lead complex generative, formative, and summative HF/UE studies (design, protocols, execution, analysis, reporting).
- Conduct/oversee use-related risk analysis (URRA), task analysis, known use problems analysis, and use-related risk control evaluation.
- Contribute to regulatory strategy and support health authority submissions/interactions.
- Mentor and develop HF/UE team members; foster excellence and continuous learning.
- 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/oversee external vendors and consultants supporting HF/UE studies.
Qualifications
Basic
- Bachelor’s in Engineering, Human Factors Psychology, Industrial Design, Life Sciences, or related.
- 10+ years progressive experience in medical device/product human factors and usability engineering (incl. combination products).
- Expertise in FDA HF guidance and standards: IEC 62366-1:2015+A1:2020, ISO 14971:2019, ISO 13485, and EMA guidelines.
- Ability to lead complex HF/UE programs across concurrent projects with minimal oversight.
- Strategic influence across cross-functional teams; strong HF/UE process implementation.
- Expertise in generative research, formative evaluation, summative validation, and use-related risk analysis.
- Excellent written/spoken English communication; ability to travel up to 20%.
Preferred
- Master’s degree (related fields).
- Experience across additional disciplines (design, regulatory/risk, requirements generation, clinical practice, or post-market).
- Experience leading FDA submissions/regulatory interactions (FDA/EMA/Notified Bodies).
- Portfolio-level HF/UE strategy and governance experience.
- Knowledge of IFU and instructional design for combination products or medical devices.
Benefits (as stated)
- Health and wellbeing benefits, including high-quality healthcare and prevention/wellness programs.
- At least 14 weeks’ gender-neutral parental leave.
- Lead HF/UE strategy and execution across multiple programs and business units, applying human factors engineering from early engagement through LCM.
- Drive user-centered design across the portfolio, grounding user needs, use requirements, and UI decisions in robust research and risk-based thinking.
- Shape and continuously improve HF/UE processes, methodologies, tools, and templates aligned with FDA expectations and global standards.
- Lead complex generative, formative, and summative HF/UE studies (design, protocols, execution, analysis, reporting).
- Conduct/oversee use-related risk analysis (URRA), task analysis, known use problems analysis, and use-related risk control evaluation.
- Contribute to regulatory strategy and support health authority submissions/interactions.
- Mentor and develop HF/UE team members; foster excellence and continuous learning.
- 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/oversee external vendors and consultants supporting HF/UE studies.
Qualifications
Basic
- Bachelor’s in Engineering, Human Factors Psychology, Industrial Design, Life Sciences, or related.
- 10+ years progressive experience in medical device/product human factors and usability engineering (incl. combination products).
- Expertise in FDA HF guidance and standards: IEC 62366-1:2015+A1:2020, ISO 14971:2019, ISO 13485, and EMA guidelines.
- Ability to lead complex HF/UE programs across concurrent projects with minimal oversight.
- Strategic influence across cross-functional teams; strong HF/UE process implementation.
- Expertise in generative research, formative evaluation, summative validation, and use-related risk analysis.
- Excellent written/spoken English communication; ability to travel up to 20%.
Preferred
- Master’s degree (related fields).
- Experience across additional disciplines (design, regulatory/risk, requirements generation, clinical practice, or post-market).
- Experience leading FDA submissions/regulatory interactions (FDA/EMA/Notified Bodies).
- Portfolio-level HF/UE strategy and governance experience.
- Knowledge of IFU and instructional design for combination products or medical devices.
Benefits (as stated)
- Health and wellbeing benefits, including high-quality healthcare and prevention/wellness programs.
- At least 14 weeks’ gender-neutral parental leave.