Senior Product Manager - SaMD (Hybrid)

Ceribell, Inc•Sunnyvale, CA

4h•$149,000 - $192,000•Hybrid

About The Position

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! 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.

Requirements

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.
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 lifecycle.
Ability to decompose complex clinical workflows into clear, testable requirements and acceptance criteria that hold up under design control review.
Ability to conduct market research and translate findings into product requirements, adapting to diverse regulatory and competitive landscapes.
Excellent communication and presentation abilities, with a strong empathy for the customer and a passion for storytelling.
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.
Ability to work closely with design teams to create innovative and customer-centric solutions.
Proven ability to drive complex, multi-workstream projects through the full development lifecycle, holding schedules and delivering high-quality results on time.
Committed to upholding Ceribell’s Business Principles and driving continuous improvement in processes and outcomes.
Capable of thriving in a rapidly changing environment where continuous innovation is key to success.

Nice To Haves

MBA, MS, PhD preferred.
At least three (3) years of consulting experience and device sales experience is a plus.
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.

Responsibilities

Manage the business case, identify Ceribell’s value proposition, define the customer experience, and oversee product requirements from concept through launch and customer adoption.
Collaborate with AI, machine learning, and data science teams to incorporate advanced AI-driven features into product offerings.
Ensure product strategies align with FDA and global regulatory requirements, particularly in the context of AI and Software as a Medical Device (SaMD).
Lead the development of products specifically tailored for neurodiagnostics, with a strong focus on EEG technologies in critical care settings.
Own release planning and scope trade-offs, tracking features through design, development, verification, and launch across diverse regulatory landscapes and regions.
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.
Collect, implement, and maintain global VOC feedback to guide product development and refine market strategies.
Draft development status and release updates for Ceribell’s senior leadership, ensuring alignment across the organization.
Gather and analyze information on competitive products, including features, benefits, pricing, regulatory, clinical, and marketing status.
Other responsibilities as assigned by your Manager/Supervisor

Benefits

Performance-based incentive compensation (varies by role)
Equity opportunities
100% Employer paid Health Benefits for Employees
50% - 70% Employer paid Health, Dental & Vision for dependents (depending on plan selection)
100% paid Life and Long-Term Disability Insurance
401(k) with a generous company match
Employee Stock Purchase Plan (ESPP) with a discount
Monthly cell phone stipend
Flexible paid time off
13 Paid Holidays + 3 Company Wellness Days
Excellent parental leave policy
Fantastic culture with tremendous career advancement opportunities
Joining a mission-minded organization!