HFUE Associate Director

Main Responsibilities:
- Lead HF/UE strategy and execution across multiple programs and business units, applying human factors engineering from early engagement through lifecycle management (LCM)
- Drive user-centered design processes, ensuring user needs, use requirements, and UI design decisions are grounded 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 current FDA expectations and global standards
- Lead complex generative, formative, and summative HF/UE studies (study design, protocol development, execution, data analysis, 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 foster continuous learning
- Collaborate cross-functionally with design, regulatory, clinical, quality, and marketing teams
- Ensure HF/UE compliance and best practices (UEF/DHF deliverables, design controls, and 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, usability engineering, and/or combination product human factors engineering
- Mastery of relevant FDA HF guidance, IEC 62366-1:2015+A1:2020, ISO 14971:2019, ISO 13485, and EMA guidelines
- Proven ability to lead/manage complex HF/UE programs with minimal oversight
- Strong strategic thinking; proven influence across cross-functional teams
- Expertise in generative research, formative evaluation, summative validation, and use-related risk analysis
- Excellent written/spoken English communication; ability to present complex concepts to diverse audiences
- Ability to travel to study sites (up to 20%)

Preferred Qualifications:
- Master’s degree in related field
- Experience beyond HF/UE across design/engineering/regulatory/risk/requirements generation/clinical/post-market activities
- Experience leading FDA submissions and regulatory interactions (FDA, EMA, Notified Bodies)
- Portfolio-level HF/UE strategy and cross-functional governance experience
- Knowledge of IFU and instructional design for combination products or medical devices