Senior Human Factors Researcher ( Chicagoland-based Contractor)

Senior Human Factors Researcher ( Chicagoland-based Contractor) Bold Insight - 5.0 Chicago, IL Job Details Contract 3 hours ago Qualifications Health sciences research Product development research management Research project technical leadership Managing design projects Team management Ergonomics in industrial design Project management in healthcare Leading team collaboration initiatives Biomedical regulatory compliance Managing projects User research for product design FDA regulations Full Job Description We are booking a surge of medical device HF studies in Chicago, and we need a senior researcher who can step in on a project basis, lead formative and validation work, and keep teams moving. If you care about safe and effective use and delivering a client experience that truly exceeds expectations, this role is for you. Half of our work focuses on medical device human factors. We run exploratory research to better understand use-related needs, then guide design so products are intuitive and safe. We also conduct validation studies to confirm safe and effective use. You will work across drug delivery devices, diagnostics, surgical systems, packaging and labeling, and the digital tools that support care.

The result is tangible:

products that make a real difference for patients, caregivers, and healthcare providers. What you'll do Lead and contribute to HF engagements from planning through readout while aligning to budgets, timelines, and objectives. Manage projects and project teams to deliver strong work at every client touchpoint 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 studies in real-world use Facilitate and execute formative and summative HF research studies; moderate sessions and perform root cause analysis with clear risk controls Analyze qualitative and quantitative data, connect findings to clear design and risk management actions, and track residual risks Facilitate real-time debriefs to client stakeholders, develop HF compliant documentation that meets regulatory standards and deliver decision-ready recommendations for product, quality, and engineering teams, while creating touchpoints that consistently exceed expectations What you'll bring Depth 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 Confidence collaborating with clients and cross-functional teams, and a steady focus on a high-quality client experience Commitment to ethics and participant care, and a habit of meticulous documentation

Experience Required:

experience managing and executing HF research according to

IEC 62366

‑1, IEC/TR 62366‑2, ANSI/AAMI HE75, and FDA guidance on Applying Human Factors and Usability Engineering to Medical Devices 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 6+ years of HF research experience, including 3+ years leading complex studies or project teams 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?