Usability Engineer

Role: Usability Engineer – Medical DeviceLocation: St. Paul, MN or Los Angeles, CAWork Arrangement: Remote with Some TravelJob Type: ContractWe are seeking an experienced Usability Engineer with strong medical device experience to support a major software release and upcoming clinical trials.The ideal candidate will have hands-on experience developing Clinical Evaluation Protocols (CEP) and authoring Clinical Evaluation Reports (CER), along with knowledge of cardiovascular or structural heart technologies.Key ResponsibilitiesDevelop detailed usability and human factors improvement concepts for complex medical software applications.Assess the impact of UI/software changes on FDA approval and regulatory requirements.Support UI testing, usability evaluation, design activities, and software release assessments.Support verification and validation (V&V) activities.Work closely with R&D, engineering, clinical, regulatory, and product teams.Contribute to engineering documentation, user manuals, online help, and training materials.Develop, refine, and implement human factors/usability processes.Manage or coordinate internal and external development resources.Ensure compliance with FDA regulations and applicable medical device requirements.Required / Preferred ExperienceStrong hands-on experience developing Clinical Evaluation Protocols (CEP).Experience authoring Clinical Evaluation Reports (CER).Human Factors / Usability Engineering experience in the medical device industry.Experience with FDA-regulated medical software/products.Understanding of software development, usability testing, and human factors engineering.Experience evaluating the regulatory impact of software/UI changes.Strong ability to collaborate with R&D and cross-functional teams.Cardiovascular / Structural Heart DomainExperience with one or more of the following is highly preferred:Structural Heart proceduresTAVRTMVRTTVRCardiac CT planningLVOT assessmentCardiac imaging workflows