Regional Director of Outreach leading the outreach team in the Southeast US, focusing on behavioral health relationships and ensuring strategic goals are met. Responsibilities include team development, outreach strategy, and stakeholder engagement.
About the role
- Associate Director driving human factors engineering and usability strategies for CSL Behring's medical devices. Leading global strategies and collaborating with cross-functional teams to optimize user experience.
Responsibilities
- Lead the integration of human factors engineering and usability strategies for medical devices, combination products, and healthcare technologies
- Collaborate with cross-functional teams across Design, Engineering, Regulatory Affairs, Quality, and Clinical to embed human factors principles throughout the product lifecycle
- Drive global strategies, support regulatory submissions, and mentor junior staff
- Develop and implement global human factors strategies for product design and development
- Identify critical user interactions, use environments, and potential risks impacting safety and efficacy
- Integrate human factors early in the design process to minimize risk and optimize usability
- Guide interface design, labeling, and user instructions to improve user experience
- Conduct human factors risk assessments in alignment with ISO 14971 and company risk management procedures
- Plan and execute formative and summative usability studies
- Analyze study data to identify usability issues and recommend design modifications
- Document human factors and usability validation activities for regulatory submissions
- Partner with Clinical, Regulatory, Quality, and Manufacturing teams to ensure integrated design development
- Participate in project planning, milestone reviews, and senior leadership meetings.
Requirements
- Master’s or PhD in Human Factors, Industrial Design, Human-Computer Interaction, Ergonomics, Biomedical Engineering, or a related field
- 8–12 years of experience in human factors engineering, usability, or related product development
- Experience in medical devices, combination products, or healthcare technologies
- Proven experience conducting formative and summative usability studies
- Knowledge of human factors standards (IEC 62366, FDA guidance, ISO 14971)
- Expertise in human factors and usability engineering
- Strong understanding of design controls and risk management
- Experience with usability study design, execution, and analysis
- Regulatory knowledge for HF submissions and compliance
- Cross-functional collaboration and project leadership
- Excellent written and verbal communication skills.
Benefits
- Competitive compensation and benefits, including flexible working arrangements
- Professional development and advancement opportunities
- A culture that values innovation, quality, and continuous improvement
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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