Risk Assessment & Validation
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.
Regulatory & Compliance
Support preparation of HF-related sections of regulatory submissions (FDA, EU MDR, and other global authorities).
Ensure HF programs meet all relevant international standards and guidance.
Serve as a subject matter expert for regulatory inspections related to human factors.
Cross-Functional Leadership
Partner with Clinical, Regulatory, Quality, and Manufacturing teams to ensure integrated design development.
Mentor and develop junior HF staff.
Participate in project planning, milestone reviews, and senior leadership meetings.
Your Skills and Experience
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.
What We Offer
A senior leadership role shaping the usability and safety of innovative healthcare products.
The opportunity to drive global human factors strategies and influence product development.
Collaboration with diverse, cross-functional teams in a dynamic environment.
Professional development and advancement opportunities.
Competitive compensation and benefits, including flexible working arrangements.
A culture that values innovation, quality, and continuous improvement.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
