HFUE Associate Director

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. #J-18808-Ljbffr Scorpion Therapeutics