Director of Product Management
Openwater
About the Company:
Openwater is creating next-generation open-source medical technologies that can enable us to diagnose and treat potentially 100’s of diseases with a single platform. With this advancement comes the promise of treatment of debilitating diseases including cancer, mental disease, stroke, COVID/Long COVID and longevity treatments. We already have a trove of clinical data demonstrating the promise of our technology, and now Openwater is the world’s first open-source, open-patent, open-clinical-data, and open-safety-sharing company, centered on the new idea of the Silicon Hospital.
Position Overview
Openwater is seeking an experienced Director of Product Management to drive the vision, strategy, and execution of our medical device hardware and services portfolio. This is a high-visibility individual contributor role with cross-functional impact and executive-facing responsibilities. You will serve as a key contributor to product direction and a trusted advisor to company leadership. Your expertise in medical devices, regulatory strategy, and open source integration will help shape the Company’s trajectory and market position.
Key Responsibilities
Product Strategy & Execution
- Support the development and execution of product and platform strategies in alignment with the Company’s device portfolio and overall business objectives.
- Provide input to senior leadership on product direction, market trends, and investment opportunities.
- Promote a culture of innovation, agility, and operational excellence within the Company.
Product Lifecycle Management
- Oversee the end-to-end lifecycle of assigned medical device products, from concept and prototyping through clinical validation, regulatory approval, launch, and post-market support.
- Lead cross-functional teams to deliver new features, enhancements, and product updates on time and within budget.
- Ensure product roadmaps are aligned with regulatory requirements, commercial goals, and user needs.
Market & Stakeholder Engagement
- Conduct market research and competitive analysis to identify clinical needs, market trends, and technology opportunities.
- Build and maintain relationships with key stakeholders, including healthcare organizations, technology partners, and opinion leaders.
- Represent the Company at relevant industry events, partner meetings, and internal forums as a product subject matter expert.
Regulatory & Risk Management
- Collaborate with regulatory and quality teams to support global product submissions and ensure compliance with FDA, CE, ISO 13485, and other applicable standards.
- Contribute to risk management, verification/validation planning, and evidence generation activities for assigned products.
- Assist in evaluating open source components and ensuring regulatory, IP, and cybersecurity compliance.
Documentation & User Support
- Write and maintain user guides, instructions for use (IFU), and other product documentation to support safe and effective use of medical devices.
- Prepare comprehensive documentation required for product submissions and to meet regulatory standards.
- Ensure all product documentation is accurate, clear, and compliant with applicable regulatory and quality requirements.
Cross-Functional Collaboration
- Work closely with engineering, clinical, regulatory, business development, and quality teams to deliver high-impact solutions.
- Facilitate decision-making and resolve challenges using data-driven insights and cross-functional collaboration.
Qualifications
Required Skills & Experience
- Product management or related experience in medical devices, healthcare technology, or life sciences, with a proven record of launching products in regulated environments.
- Experience leading or mentoring teams or cross-functional project groups, preferably in a startup or high-growth environment.
- Solid understanding of medical device regulations (FDA, CE, ISO 13485), quality systems, and risk management processes.
- Demonstrated ability to manage the product lifecycle, from concept through launch and post-market support.
- Experience collaborating with engineering, clinical, regulatory, and commercial teams to deliver successful products.
- Familiarity with open source software, hardware, or data-sharing models in regulated settings, including basic governance and compliance considerations.
- Strong analytical, communication, and stakeholder management skills, with the ability to influence and drive results across functions.
- Bachelor’s degree in biomedical engineering, life sciences, or a related technical field.
- Hands-on experience with hardware/software development and data-driven healthcare solutions.
- Experience representing organizations at industry, regulatory, or investor events.
- Visionary mindset, adaptability, and passion for advancing healthcare technology in a startup setting.