Senior Product Manager - SaMD (Hybrid)

Position Overview:

We are seeking a highly motivated Product Manager to drive key products within Ceribell’s expanding portfolio from concept to release. This role centers on defining detailed product requirements and shepherding them through every phase of the development lifecycle. You will own the product backlog, write clear specifications and acceptance criteria, and work day to day with engineering to keep releases on schedule.

Success in this role requires deep, hands-on partnership with R&D, AI, and data science teams, as well as with sales and marketing. You will collaborate closely with key opinion leaders (KOLs) in North America and globally, translating their input into concrete requirements and design decisions. The Product Manager reports directly to the Exe. Director of Product & Design.

The primary focus for the Product Manager is to start with the customer and work backward to define the product vision and customer needs, particularly within the neurodiagnostics and critical care spaces. You will translate those needs into detailed specifications, user stories, and acceptance criteria that engineering can build against, leveraging AI to deliver groundbreaking solutions.

You will be responsible for setting the product vision and maintaining the roadmap and release plan, establishing the processes that keep development moving quickly, and driving day-to-day execution across teams from design review through verification and release. Your role will include writing product specifications, prioritizing and grooming the backlog, global voice of customer (VOC) gathering, market research, and ensuring that all product deliverables meet the highest standards of quality and compliance.

What you'll do:

• 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

What We're Looking For:

• 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%.