Senior Human Factors Engineer

Overview

As a Senior Human Factors Engineer, you will elevate user experience and ensure patient safety for diagnostic products by conducting human factors research, usability studies, and user risk analyses. You will provide user-centered design recommendations that inform product enhancements for healthcare professionals and patients.

What you'll do

• Lead Human Factors Engineering activities throughout the product development lifecycle to ensure the safe and effective use of medical devices through usability engineering and risk management principles.
• Develop and execute HFE strategies, plans, and deliverables in compliance with FDA Human Factors Guidance, IEC 62366-1, ISO 14971, and internal design control processes.
• Plan, conduct, and report user research, formative evaluations, and summative usability validation studies to identify and mitigate use-related risks and support regulatory submissions.
• Author and maintain use specifications, task analyses, critical task assessments, use-related risk analyses, and usability engineering files.
• Partner with cross-functional teams to integrate human factors into design inputs, requirements, risk management activities, verification efforts, and product development decisions.
• Provide technical leadership and mentorship.

What you'll need

• Bachelor's degree in Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Ergonomics, Psychology, Cognitive Science, Systems Engineering, or a related technical discipline.
• 5+ years of Human Factors Engineering experience in a regulated industry, including medical device or combination product development.
• Demonstrated experience applying human factors engineering principles within a design controls environment and using risk management methodologies aligned with ISO 14971.
• Experience planning, conducting, and documenting formative and summative usability studies in accordance with FDA Human Factors Guidance and IEC 62366-1.
• Strong technical writing, communication, and collaboration skills.
• Ability to work independently and influence cross-functional teams in a matrixed environment.

Nice to have

• Previous experience authoring human factors documentation supporting FDA, EU MDR, Health Canada, or other global regulatory submissions.
• Previous experience supporting the development of complex medical technologies, including infusion systems, diagnostics, patient monitoring systems, or Software as a Medical Device (SaMD).
• Previous experience applying systems engineering, FMEA, hazard analysis, fault analysis, or other risk assessment methodologies to identify and mitigate use-related risks.

Details

• Location: Bangalore, Karnataka, India.
• Work mode: On-site.
• The role is with the Beckman Coulter team at the Danaher India Development Center in Bangalore.