Senior Human Factors Engineer

DHR Holding India; Bengaluru; On-site; INR 3,000,000 - 4,600,000; Full time

Job summary

Beckman Coulter in Bengaluru is seeking a Senior Human Factors Engineer to elevate user experience and patient safety for cutting-edge diagnostic products. You will lead HF research, usability studies, and risk analyses to inform product enhancements for healthcare professionals and patients.

The role is on-site at the Danaher India Development Center (IDC), Bangalore, with collaboration across multiple business segments and a focus on cloud and data analytics within HF engineering.

Qualifications

• Bachelor’s degree in a technical discipline with Human Factors focus.
• 5+ years in Human Factors Engineering within regulated environments (medical devices).
• Experience applying design controls and ISO 14971 risk methodologies.

Responsibilities

• Lead HF engineering activities across product development lifecycle to assure safe use of medical devices.
• Develop and execute HF strategies, plans, and deliverables per FDA/IEC guidelines.
• Plan, conduct, document formative and summative usability studies for regulatory submissions.
• Author and maintain vital HF deliverables: use specs, task analyses, risk analyses, usability files.
• Collaborate with cross-functional teams to integrate HF into design inputs and risk management.

Skills

Technical writing

Cross-functional work

Stakeholder communication

Risk assessment

Regulatory awareness

Education

Bachelor's degree in Human Factors

Biomedical Engineering

Industrial Engineering

Ergonomics

Cognitive Science

Job description

Job Summary

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-your user-centric design recommendations will directly inform product enhancements, making our solutions more intuitive, safer, and ultimately, more effective for healthcare professionals and the patients they serve.

This position of Senior Human Factors Engineer is for Beckman Coulter team located at Danaher India Development Center (IDC), Bangalore and will be an on-site role. IDC is a research and development center with the vision of accelerating product roadmaps across various Danaher business segments. The operating companies include Beckman Coulter, Radiometer, Leica Bio Systems, HemoCue, Cepheid and more. The IDC workforce comprises various product engineering teams, working on development of software and hardware components of cutting-edge products for Immunoassay, Chemistry, Hematology, Molecular diagnostics, Oncology, Neurosurgery and Water Quality. IDC has evolved as center of excellence for Cloud and data analytics, with significant contributions to the key informatics solutions. The teams consist of highly hardworking software hardware engineers and development managers. The teams are supported by local Product managers, Quality Regulatory and Intellectual property specialists.

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.
• 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 key HFE deliverables, including 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 while providing technical leadership and mentorship.

Requirements

• Bachelors 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.

Preferred qualifications

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

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.