Senior Product Manager Samd Diagnostics

## About the Company Heuristyx Neural Diagnostics is an innovative company focused on creating transformative software as medical device (SaMD) solutions to revolutionize neurodegenerative disease diagnostics, starting with Alzheimer's disease. Committed to advancing patient outcomes, Heuristyx Neural Diagnostics leverages cutting-edge technology and collaborative expertise to address critical diagnostic challenges. The company is headquartered in the vibrant San Francisco Bay Area, fostering an environment of innovation and excellence. By combining science, technology, and dedicated talent, Heuristyx Neural Diagnostics is at the forefront of redefining diagnostic precision and efficiency in healthcare. ## About the Role Senior Product Manager will be responsible for establishment and periodic revisions of comprehensive set of requirements for novel SaMD (Software as Medical Device) application software for diagnosing Alzheimer's disease early and for periodically notifying patients of FDA-approved Alzheimer's drugs and open clinical trials of new Alzheimer's drugs. Initially PM will develop functional SaMD iOS application software using Claude Code or similar AI software development tool for creating Gen 0 app, for initial evaluation of app functionality, user feedback, finalizing SaMD app requirements, and demos. Subsequently PM will be primary contact working with Andersen Lab team, who will be using supervised machine learning algorithms to develop an Alzheimer's diagnostic classification model, which they subsequently will incorporate into the Gen 1.0 SaMD apps for iOS, Android, MacOS, and Windows devices. Following market release of Gen 1.0 apps, PM will be responsible as primary contact during Andersen Lab team's development and QA testing of Gen 2.0 and future app generations for iOS, Android, MacOS, and Windows devices. ## Responsibilities - Establish and periodically revise a comprehensive set of requirements for novel SaMD (Software as Medical Device) application software for diagnosing Alzheimer's disease early. - Periodically notify patients of FDA-approved Alzheimer's drugs and open clinical trials of new Alzheimer's drugs. - Develop functional SaMD iOS application software using Claude Code or similar AI software development tool for creating Gen 0 app. - Conduct initial evaluation of app functionality, gather user feedback, finalize SaMD app requirements, and prepare demos. - Serve as primary contact working with Andersen Lab team, who will be using supervised machine learning algorithms to develop an Alzheimer's diagnostic classification model. - Incorporate the developed model into the Gen 1.0 SaMD apps for iOS, Android, MacOS, and Windows devices. - Serve as primary contact during Andersen Lab team's development and QA testing of Gen 2.0 and future app generations for iOS, Android, MacOS, and Windows devices following the market release of Gen 1.0 apps. ## Requirements ### Minimum Qualifications - 5+ years' experience as Product Manager with either healthcare, medical diagnostics, or SaMD software apps. - Experience with one or more of the following operating systems: iOS, Android, MacOS, and Windows. - Experience using Claude Code or similar AI tool to successfully create one or more apps. - Experience working with cross-functional teams, including software engineers, UX designers, and clinical subject matter experts. - Strong communication, leadership, and problem-solving skills. - B.S. degree in Computer Science or comparable field. ### Preferred Qualifications - Senior SaMD Product Manager with experience interfacing with overseas development and QA teams, successfully launching multiple SaMD apps. - Experience with FDA regulatory requirements such as IEC 62304 software validation standards and QMSR compliance which incorporates ISO 13485: 2026. - Project management experience (MS Project or equivalent). - Experience working in an early-stage software development startup. - M.S. degree in Computer Science or comparable field. - MBA degree, with experience in marketing or business development. - Based in San Francisco Bay Area. ## What We Offer - Initial: Equity Only - Post-Funding (investors and/or government grants): Salary TBD