Senior Human Factors Engineer

Danaher Corporation; Bengaluru; On-site; INR 2,500,000 - 3,800,000; Full time

Job summary

Beckman Coulter Diagnostics, part of Danaher, seeks a Senior Human Factors Engineer in Bengaluru on-site at the Danaher IDC. You will lead usability studies, risk analyses, and HFE deliverables to ensure safe, effective use of diagnostics products.

In this role, you will partner with product, software, regulatory, and quality teams to integrate human factors into design inputs and risk management, with strong technical writing and mentorship expected.

Qualifications

• Bachelor's degree in a technical discipline with focus on human factors.
• 5+ years in Human Factors Engineering within regulated medical device or similar.
• Experience applying human factors principles in design controls and ISO 14971.

Responsibilities

• Lead HFE activities across product development to ensure safe use of medical devices.
• Plan, conduct, and report formative and summative usability studies.
• Prepare use specifications, task analyses, and usability files.
• Collaborate with cross-functional teams and mentor juniors.

Skills

Human Factors Engineering

Regulatory submissions

FDA guidance

IEC 62366-1

ISO 14971

Usability studies

Risk management

Technical writing

Cross-functional collaboration

Mentorship

Education

Bachelor's degree in Human Factors Engineering or related

Tools

FMEA

Hazard analysis

Design controls

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Beckman Coulter Diagnostics, one of Danaher's (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives - and we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.

As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making - we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.

Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

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. Started in 2014, the center now hosts 500+ associates, for multiple Danaher operating companies focusing on Diagnostics and Life Science. The operating companies includes Beckman Coulter, Radiometer, Leica Bio systems, HemoCue, Cepheid and more.

The IDC workforce comprises of 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.

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. 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.

In this role, you will have the opportunity to:

• 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. The essential requirements of the job include:
• 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. It would be a plus if you also possess previous experience in:
• 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.

For more information, visit www.danaher.com .

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

Operating Company: Cepheid