Director, Human Factors, Usability and Risk

Role Summary

Lead and strategically oversee the integration of human factors engineering, user insights, and risk management across the medicine and vaccine development portfolio. Provide enterprise-level direction to assess and continually improve existing capabilities, ensuring user-centric product designs, alignment with the CMC Operating Model, and regulatory compliance for Medical Devices and Combination Products across the full product lifecycle. Locations include USA: Pennsylvania (Upper Providence) and Massachusetts (Waltham); UK: Hertfordshire (Ware).

Responsibilities

• Strategic leadership and capability assessment to develop and drive a strategic vision for HFE, UI, and RM that supports a broad portfolio of combination products and implement continuous improvements across the full product ecosystem.
• Foster an enterprise culture that integrates human factor engineering (HFE) and risk management (RM) early and across the product development lifecycle, ensuring seamless incorporation into the design control framework and regulatory submissions while ensuring lifecycle success.
• Oversee and manage risk-based approaches while integrating best practices to address regulatory challenges, integrate with combination product design and manufacturing risk assessments, ensure compliance with relevant standards and regulatory requirements (FDA, EMA, etc.), and minimize on-market risks.
• Embed design-enabling patient and user insights in early-stage concept development, ensuring alignment with CMC models and product design requirements.
• Direct and oversee literature data gathering, anthropometric research, and formative and summative HF studies aimed at creating design solutions to meet user needs.
• Interface effectively with cross-functional teams (Device Development, Medical, Packaging, Regulatory, CMC, Drug Product, etc.) and internal partners (e.g., MSAT, APS, etc.) to ensure integrated and harmonized product development.
• Collaborate with Post-Market Surveillance (PMS) on collecting real-world data (complaints, adverse events, user feedback, etc.) and drive update of risk assessments and implementation of corrective actions to ensure long-term product safety and effectiveness.
• Manage a skilled internal team supported by an external partnership framework to ensure effective and efficient execution; coach and mentor team members to foster proactive engagement within product development process, the CMC Operating Model and broader project teams.
• Assess and evaluate flexible, scalable models for collaboration internally and externally to support program and strategic deliverables while staying abreast of industry practices, regulatory trends, and portfolio needs / challenges to refine processes and framework.
• Set vision and communicate operational strategies, opportunities, and progress to senior leadership and key stakeholders / partners to drive product success and enterprise capability.

Qualifications

• Required: Bachelor’s degree in human factors, industrial design, engineering, psychology, nursing, or related field, plus significant relevant experience. Advanced degree preferred.
• Required: Demonstrated record of scientific achievement and a broad and integrated knowledge of Human Factors, IFU development, Combination Product requirements, Risk Management for Medical Devices, and application of User Insights and / or Patient Support needs across the product lifecycle.
• Required: Understanding of relevant regulatory and compliance standards, including ISO standards, MDR, Design Controls, etc. And ability to review / author regulatory documents and responses.
• Preferred: Advanced degree (MS, PhD) in human factors, ergonomics, industrial design, or related discipline.
• Preferred: Experience leading or managing human factors teams or matrixed resources.
• Preferred: Hands-on experience with medical device, combination product, or packaging usability work.
• Preferred: Familiarity with quantitative and qualitative research methods, and experience with statistical analysis of usability data.
• Preferred: Experience working in global, cross-cultural teams and supporting multiple geographic regulatory requirements.
• Preferred: Certification or formal training in human factors, usability engineering, or risk management.

Skills

• Human factors engineering and usability engineering
• User insights and patient support needs integration
• Risk management for medical devices and combination products
• Regulatory knowledge and support for submissions (FDA, EMA, MDR, ISO Design Controls)
• Design control implementation and lifecycle alignment with CMC Operating Model
• Literature data gathering, anthropometric research, formative and summative HF studies
• Cross-functional collaboration with Device Development, Regulatory, Packaging, CMC, Drug Product; internal partners (MSAT, APS)
• Post-market surveillance collaboration and handling real-world data
• People leadership, mentoring, and external partnership management
• Strategic thinking and enterprise capability development; communication to senior leadership

Education

• Bachelor’s degree in human factors, industrial design, engineering, psychology, nursing, or related field. Advanced degree preferred.

Additional Requirements

• Location: United States-based with hybrid working arrangement. On-site regularly for team collaboration, lab-based studies, and stakeholder meetings. Occasional travel may be required.