Senior Product Manager (SaMD)

TL;DR

Senior Product Manager (SaMD): Driving the development of AI-powered neurodiagnostic and EEG platforms within the acute care setting with an accent on regulatory compliance (FDA) and customer-centric design. Focus on translating complex clinical workflows into technical requirements and managing the full product lifecycle from concept to launch.

Location: Hybrid in Sunnyvale, CA

Salary: $149,000 - $192,000 USD

Company

hirify.global is a medical technology company transforming the diagnosis and management of patients with serious neurological conditions through its point-of-care EEG platform.

What you will do

• Manage end-to-end product ownership from business case and value proposition to launch and customer adoption.
• Collaborate with AI, machine learning, and data science teams to integrate advanced AI-driven features into product offerings.
• Ensure product strategies align with FDA and global regulatory requirements for Software as a Medical Device (SaMD).
• Lead the development of products tailored for neurodiagnostics and EEG technologies in critical care settings.
• Own release planning, backlog grooming, and execution across design, verification, and launch phases.
• Gather global Voice of Customer (VOC) feedback and conduct competitive market analysis to refine strategies.

Requirements

• Bachelor’s degree in marketing, business, clinical science, or engineering; MBA, MS, or PhD preferred.
• Minimum 7 years of experience in medical device or medical software product development.
• Extensive knowledge of FDA 510(k) submissions and 21 CFR 820.30 design controls.
• Ability to decompose complex clinical workflows into clear, testable requirements and acceptance criteria.
• Technical proficiency with Agile ceremonies and backlog management tools such as Jira.
• Ability to travel up to 25%.

Nice to have

• At least three years of consulting experience.
• Previous experience in medical device sales.
• Strong background in neurodiagnostics, specifically EEG technologies.

Culture & Benefits

• 100% employer-paid health benefits for employees and partial coverage for dependents.
• 401(k) with company match and Employee Stock Purchase Plan (ESPP) with a discount.
• Flexible paid time off, 13 paid holidays, and 3 company wellness days.
• Performance-based incentive compensation and equity opportunities.
• Comprehensive parental leave policy and monthly cell phone stipend.