CSL
CSL
CSL is a global biotechnology and healthcare company developing biotherapeutics and vaccines for people living with serious and rare diseases. Its operations include CSL Behring, which provides treatments for immunodeficiency, hereditary bleeding disorders, and Alpha-1 Antitrypsin Deficiency; CSL Seqirus, a major influenza vaccine provider; and CSL Vifor, focused on iron deficiency and nephrology. Supported by a broad research and development network, CSL works across plasma fractionation, recombinant protein technology, cell and gene therapy, and vaccines. Headquartered in Melbourne, Australia, the company serves patients in more than 100 countries and offers career opportunities across research, manufacturing, healthcare, and biotechnology.

Associate Director, Human Factors Engineering — CSL, Onsite in Kgs. Lyngby

Lead human factors engineering and usability strategy for CSL Behring medical devices and healthcare technologies. Direct global validation programs, regulatory support, and cross-functional product development.

Description

  • Create and execute global human factors strategies across product design and development
  • Assess critical user interactions, use environments, and risks affecting safety and efficacy
  • Embed human factors throughout design to reduce risk and improve usability
  • Own human factors inputs, design controls, and usability engineering across the product lifecycle
  • Shape interfaces, labeling, and user instructions to enhance the user experience
  • Partner with R&D, Engineering, Product Development, Clinical, Regulatory, Quality, and Manufacturing teams
  • Perform human factors risk assessments under ISO 14971 and company risk management procedures
  • Plan and deliver formative and summative usability studies
  • Evaluate study findings and recommend design changes
  • Prepare human factors and usability validation documentation for regulatory submissions
  • Contribute human factors content to FDA, EU MDR, and other global regulatory submissions
  • Maintain compliance with applicable international human factors standards and guidance
  • Act as the human factors subject matter expert during regulatory inspections
  • Coach and develop junior human factors professionals
  • Contribute to project planning, milestone reviews, and senior leadership discussions

Requirements

  • Master’s degree or PhD in Human Factors, Industrial Design, Human-Computer Interaction, Ergonomics, Biomedical Engineering, or a related discipline
  • 8–12 years of experience in human factors engineering, usability, or related product development
  • Background in medical devices, combination products, or healthcare technologies
  • Demonstrated experience running formative and summative usability studies
  • Working knowledge of IEC 62366, FDA human factors guidance, and ISO 14971
  • Advanced expertise in human factors and usability engineering
  • Strong command of design controls and risk management practices
  • Experience designing, conducting, and analyzing usability studies
  • Understanding of human factors regulatory submissions and compliance
  • Ability to lead projects and collaborate across functions
  • Excellent written and verbal communication skills

Benefits

  • Opportunities for professional growth and career advancement
  • Competitive compensation and benefits package
  • Flexible working arrangements
  • Workplace culture centered on innovation, quality, and continuous improvement
  • Inclusive culture with a strong focus on belonging
  • Reasonable accommodation available for applicants with disabilities

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