Senior Human Factors Engineer

Role overview

Senior Human Factors Engineer at Beckman Coulter Diagnostics

Responsibilities

• Lead Human Factors Engineering (HFE) activities throughout the product development lifecycle, ensuring the safe and effective use of medical devices through application of 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.
• Author and maintain key HFE deliverables, including use specifications, task analyses, critical task assessments, use-related risk analyses, and usability engineering files.

Preferred qualifications and skills

• It would be a plus if you also possess previous experience in.

Employment details

• Location: Bangalore [Karnātaka] [India]

Benefits

• Supporting the development of complex medical technologies, including infusion systems, diagnostics, patient monitoring systems, or Software as a Medical Device (SaMD).

Additional role details

• As a Human Factors Engineer, you will play a vital role in elevating the user experience and ensuring patient safety for our cutting-edge diagnostic products.
• By actively planning and conducting human factors research – from critical usability studies to thorough user risk analyses – you'll uncover key insights.
• Plan, conduct, and report user research, formative evaluations, and summative usability validation studies to identify and mitigate use-related risks and support regulatory submissions.
• Partner with cross-functional teams to integrate human factors into design inputs, requirements, risk management activities, verification efforts, and product development decisions while providing technical leadership and mentorship.
• 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, with the ability to work independently and influence cross-functional teams in a matrixed environment.
• Authoring human factors documentation supporting FDA, EU MDR, Health Canada, or other global regulatory submissions.
• Applying systems engineering, FMEA, hazard analysis, fault analysis, or other risk assessment methodologies to identify and mitigate use-related risks.
• Learn about the Danaher Business System which makes everything possible.