Sr Human Factor Engineer

Responsibilities

• Lead and execute human factors engineering (HFE) activities throughout the product development lifecycle for IVD and medical devices.
• Conduct user research, including contextual inquiry and formative usability testing, to identify user needs and pain points.
• Translate user research findings into actionable design requirements, specifications, and detailed task analyses.
• Develop and execute comprehensive design and HFE validation plans, including summative usability testing.
• Analyze usability study data to identify critical user interface issues, risks, and opportunities for improvement.
• Prepare technical documentation and human factors reports for internal stakeholders and regulatory submissions (FDA, EU MDR, IVDR).
• Collaborate cross-functionally with R&D, Marketing, Quality, and Regulatory teams to integrate HFE principles into product design.
• Participate in risk management activities, including use-related risk analysis and uFMEA.

Requirements

• Bachelor's degree in Human Factors Engineering, Biomedical Engineering, Industrial Design, Cognitive Science, or a related field (Master's degree preferred).
• 7+ years of experience in human factors engineering and design validation within the medical device industry.
• Strong understanding of IVD/medical device regulations and standards, specifically IEC 62366-1 and AAMI HE75.
• Proven experience in planning, executing, and reporting on formative and summative usability studies.
• Demonstrated ability to translate user research into design requirements and specifications.
• Proficiency with usability testing tools and software.
• Excellent analytical, problem-solving, and technical communication skills.

Benefits

• Competitive salary and annual bonus.
• Hybrid working model (3 days on site, 2 days home office).
• Company restaurant and contribution to fitness subscriptions.
• Training and development programs, including access to LinkedIn Learning.
• Employee assistance programme and referral scheme.

About the Company

Bio-Rad is involved in the supply of high-quality products and services intended for diagnostic laboratories. Our culture is built on independence, innovation, and a strong commitment to our customers within a multicultural environment.