Human Factors Engineer III Location US-Bothell ID 2024-1206 Category Engineering Position Type Full-Time Work Model Onsite Company Overview Verathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and airway management. The company's BladderScan portable ultrasound and GlideScope video laryngoscopy & bronchoscopy systems effectively address unmet needs for healthcare providers and meaningfully raise the standard of care for patients. Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific. For more information, please visit www.verathon.com. Overview Verathon is seeking a Human Factors Engineer become the newest member of our Visualization Business Unit R&D Team in Bothell, WA. The Human Factors Engineer is responsible for ensuring our products are safe and easy to use. As part of the new product development process, you will have primary responsibility for formative and summative usability studies to test understanding of our products and labeling. The Human Factors Engineer will work closely with product planning to test product concepts and feed this information back to the design teams to optimize use of our products. This person will also work closely with the quality and regulatory groups to create the usability and Human Factors documentation required for submission to medical device regulatory agencies. Responsibilities * Participate and provide usability input during the initial product concept design process.* Create the user requirements and specification documents.* Create use and human factors plans and protocols* Conduct formative usability research and create appropriate documentation to inform needed design changes* Participate in efforts required to create and update usability risk analyses for VBU products.* Provide input to key use related documents and activities, including user needs, product labeling, and the system risk assessment.* Create plans and protocols to validate indications for use, user needs, usability risk mitigations, labeling, and product claims* Conduct summative usability validation studies, including ultimate responsibility for user recruiting and testing* Write usability validation reports* Support content transfer into summary V&V and Safety Risk Management reports* Perform document regression analyses for legacy product design changes* Prepare documentation for submission to regulatory agencies and notified bodies, including HFE/UE Reports* Maintain current knowledge of regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices) * Conduct post-use usability testing, providing input to NPD and sustaining project prioritization.* Advise management regarding potential improvements to internal processes and regulatory issues related to usability engineering. Qualifications * Bachelor's degree in relevant field; Master's preferred.* Typically, a minimum of 5 years of human factors experience, Medical device experience is desired.* Familiarity with Use and Human Factors standards and regulatory guidelines regarding proper validation procedures* Ability to work on multiple projects at the same time - exceptional organizational and time management skills* Strong use and human factors research skills* Ability to analyze and synthesize large quantities of information* Superior ability