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Overview:
SafeBeat Rx is a cardiovascular care company focused on serving cardiovascular patients nationwide.
We are seeking an experienced Human Factors Expert to consult on the human factors engineering aspects of our Software as a Medical Device (SaMD) 510(k) submission. The consultant will play a key role in ensuring that our product meets FDA requirements for usability and patient safety, focusing on how users interact with the software, risk mitigation, and enhancing user experience.
Key Responsibilities:
* Lead and Guide: Develop the human factors engineering (HFE) portion of the 510(k) submission for our SaMD.
* Collaborate with Teams: Work with cross-functional teams (engineering, quality, regulatory, and clinical) to define user needs, identify potential risks, and develop use-related risk mitigations.* Conduct Assessments: Perform user interface (UI) assessments, including usability testing and heuristic evaluations, as required for FDA submissions.* Validation Plans: Create human factors validation plans and protocols, ensuring alignment with FDA guidance documents (e.g., FDA Human Factors and Usability Engineering guidance for medical devices).* Facilitate Studies: Lead human factors usability studies with relevant user groups (e.g., healthcare professionals and patients).* Analyze Results: Analyze usability testing results and prepare detailed reports, identifying necessary design changes or further testing.* Documentation Compliance: Ensure all human factors documentation is compliant with regulatory standards and ready for submission as part of the 510(k) process.Qualifications:
* Experience Required: Proven experience with human factors engineering and usability testing in the medical device or healthcare software field.
* FDA Guidance Knowledge: Familiarity with FDA guidance on human factors for medical devices (including IEC 62366-1 and AAMI HE75 standards).* Documentation Preparation: Experience preparing human factors engineering documentation for 510(k) submissions, preferably for SaMD.* Usability Study Design: Ability to design and execute usability studies, including formative and summative evaluations.* Collaboration Skills: Excellent collaboration and communication skills with both technical and non-technical stakeholders.* Analytical Attention: Strong analytical skills with attention to detail in identifying and mitigating potential risks.* Team Integration: Experience working with cross-functional teams to integrate human factors principles into product development.Preferred Experience:
* Regulated Environments: Background in human factors or usability within regulated environments (e.g., FDA, MDR).
* Advanced Degree: Advanced degree in human factors engineering, ergonomics, cognitive psychology, or related fields.* Certification: Certification in human factors, ergonomics, or usability testing is a plus.Please reach out with your interest and CV.
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