Onsite Associate Director, Human Factors Design – Development

Posted 5 hours ago

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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

Associate Director, Human Factors Design – Development

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Postgraduate Degree

Location requirements

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