Human Factors Specialist I

GLAUKOS - HUMAN FACTORS SPECIALIST I

At Glaukos, we're committed to advancing innovative ocular therapies that improve patients' quality of life. As part of our Research & Development team, the Human Factors Specialist ensures our products are safe, intuitive, and designed with the end user in mind. In this role, you'll collaborate across disciplines to transform insights from clinicians and patients into meaningful design solutions that support global regulatory compliance and exceptional product performance.

How will you make an impact?

The Human Factors Specialist will perform a variety of Human Factors / Usability Engineering (HFUE) validation activities based on Risk Management of ocular related products to support product design, concept testing, early development, clinical testing, and sustaining activities.

The Specialist play a key role in ensuring the safety, effectiveness, and ease of use of our ocular-related medical and combination products. By applying human factors and usability engineering principles, you'll help shape product designs that meet user needs, reduce risk, and comply with global regulatory standards. Your work will directly influence how our products perform in the hands of clinicians and patients worldwide.

What will you do?

• Plan and execute human factors and usability engineering (HFUE) studies, including formative and summative evaluations.
• Identify and assess use-related risks and recommend design improvements throughout product development.
• Partner with engineering, design, quality, regulatory, and medical safety teams to ensure user needs and risk controls are effectively integrated.
• Prepare and maintain HFUE documentation including protocols, reports, and design control deliverables.
• Support design control, verification, validation, and risk management activities in alignment with FDA and ISO standards (e.g., IEC 62366, HE75, EN ISO 14971).
• Advocate for end users through data collection, usability analysis, and application of user-centered design best practices.

How will you get here?

• Bachelor's degree in Engineering (Chemical, Biomedical, or related field).
• 0-2 years of experience; at least 1 year of HFUE experience preferred.
• Knowledge of human factors and usability standards and medical device regulations (FDA HFUE Guidance, IEC 62366, HE75, EN ISO 14971).
• Experience with ocular devices, wet/dry lab setups, or cross-functional product development a plus.
• Strong analytical, communication, and documentation skills.
• Proficiency in Microsoft Office Suite.
• HFUE coursework or certification preferred.

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