Senior Product Manager - SaMD (Hybrid)

Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel, point-of-care electroencephalography (“EEG”) platform specifically designed to address the unmet needs of patients in the acute care setting, and is being used in hundreds of community hospitals, large academic facilities and major IDN's across the country. Our entire team is driven by a shared commitment to transforming the landscape of critical care through our rapid seizure detection technology, come join the movement!

• →End-to-End Product Ownership: Manage the business case, identify Ceribell’s value proposition, define the customer experience, and oversee product requirements from concept through launch and customer adoption. 

• →AI Integration: Collaborate with AI, machine learning, and data science teams to incorporate advanced AI-driven features into product offerings. 

• →Regulatory and Compliance Leadership: Ensure product strategies align with FDA and global regulatory requirements, particularly in the context of AI and Software as a Medical Device (SaMD). 

• →Neurodiagnostics Expertise: Lead the development of products specifically tailored for neurodiagnostics, with a strong focus on EEG technologies in critical care settings. 

• →Release and Lifecycle Management: Own release planning and scope trade-offs, tracking features through design, development, verification, and launch across diverse regulatory landscapes and regions. 

• →Cross-Functional Execution: Run sprint planning, backlog reviews, and design reviews with internal teams and external vendors, removing blockers and balancing time-to-market with quality and compliance. 

• →Voice of Customer (VOC): Collect, implement, and maintain global VOC feedback to guide product development and refine market strategies. 

• →Stakeholder Communication: Draft development status and release updates for Ceribell’s senior leadership, ensuring alignment across the organization. 

• →Competitive Analysis: Gather and analyze information on competitive products, including features, benefits, pricing, regulatory, clinical, and marketing status. 
• →Other responsibilities as assigned by your Manager/Supervisor

• Educational Background: Bachelor’s degree in marketing, business, biological/clinical science, or engineering is required; MBA, MS, PhD preferred. A minimum of (7) years of experience in medical device or medical software product development. 

• At least three (3) years of consulting experience and device sales experience is a plus. 

• AI and Neurodiagnostics Knowledge: Strong background in software and hardware in the medical device space with neurodiagnostics, particularly EEG technologies, and experience with AI-driven product development a plus. 

• Regulatory Expertise: Extensive knowledge of regulatory processes for, software, hardware and AI-driven medical devices, specifically FDA 510(k) submissions and 21 CFR 820.30 design controls, with direct ownership of design control deliverables through a full product development lifecycle. 
• Requirements Discipline: Ability to decompose complex clinical workflows into clear, testable requirements and acceptance criteria that hold up under design control review. 

• Market Insight: Ability to conduct market research and translate findings into product requirements, adapting to diverse regulatory and competitive landscapes. 

• Communication Skills: Excellent communication and presentation abilities, with a strong empathy for the customer and a passion for storytelling. 

• Technical Proficiency: Solid technical background with hands-on experience in medical device and software development, including agile ceremonies, backlog management tools such as Jira, and design control documentation. 

• Design Collaboration: Ability to work closely with design teams to create innovative and customer-centric solutions. 

• Project Management: Proven ability to drive complex, multi-workstream projects through the full development lifecycle, holding schedules and delivering high-quality results on time. 

• Ethics and Excellence: Committed to upholding Ceribell’s Business Principles and driving continuous improvement in processes and outcomes. 

• Agility and Innovation: Capable of thriving in a rapidly changing environment where continuous innovation is key to success. 

• Travel Requirements: Ability to travel up to 25%.