Job Description
Human Factors Researcher ( Chicagoland-based Contractor) Bold Insight - 5.0 Chicago, IL Job Details Contract 17 hours ago Qualifications Task prioritization Biomedical regulatory compliance FDA regulations Full Job Description Help us meet growing demand for safe, confident use. Our medical device HF pipeline is expanding, and we are adding contract researchers who can jump in quickly, run rigorous formative and validation work, and turn evidence into decisions. If you care about people, precision, and a client experience that consistently exceeds expectations, you'll fit right in. Why this role matters Human factors is a large part of our business. We explore use‑related needs to inform design, and we validate that products can be used safely and effectively. You will work across drug delivery devices, diagnostics, surgical tools and systems, packaging and labeling, and the digital tools that support care.
The impact is tangible:
products that make a real difference for patients, caregivers, and healthcare providers. What you'll do Contribute to HF engagements from planning through readout while aligning to budgets, timelines, and objectives. Develop human factors plans, protocols, and study materials aligned with IEC 62366
‑1, IEC/TR 62366‑2, ANSI/AAMI HE75, and FDA guidance Conduct task analyses, use‑related risk analyses, contextual inquiry, and ethnography to ground work in real use Plan and run formative human factors testing, moderate sessions, and perform root cause analysis with clear risk controls Lead or support human factors validation studies and document results for regulatory and quality audiences Analyze qualitative and quantitative data, connect findings to design and risk management actions, and track residual risks Develop HF compliant documentation that meets regulatory standard and deliver decision-ready recommendations for product, quality, and engineering teams, while creating touchpoints that consistently exceed expectations What you'll bring Foundation in HF and usability engineering for medical devices across formative and summative work Skill in task analysis, use‑related risk analysis, protocol development, moderation, and root cause analysis Ability to translate observations into a compelling narrative with prioritized recommendations tied to risk and design decisions Commitment to participant respect, ethics, and meticulous documentation Required:
familiarity with IEC 62366
‑1, IEC/TR 62366‑2, ANSI/AAMI HE75, and FDA guidance on Applying Human Factors and Usability Engineering to Medical Devices Experience Master's degree in a behavioral science or related field preferred, or comparable experience as a human factors practitioner, biomedical engineer, cognitive engineer, industrial designer, or similar 3+ years of HF research experience This position is flexibly based out of our Downers Grove and Chicago locations. Diverse projects We work in virtually every industry across hundreds of products. Collaborative team Incredibly collaborative and supportive team and fun and casual work environment. Think you're a good fit?
