EPM Scientific
Director of Product Development Job at EPM Scientific in San Francisco County
EPM Scientific, San Francisco County, CA, US
A leading global medical device company with over $4B in annual revenue is seeking a Director of Product Development to lead the creation of a next-generation platform technology. This is a rare opportunity to build a new product development function from the ground up , with full support from executive leadership and a clear path to long-term growth.
About the Company- Headquartered in San Francisco, CA , with innovation hubs across North America, Europe, and Asia .
- Focused on breakthrough technologies in minimally invasive systems, digital diagnostics, and AI-powered platforms.
- Committed to sustainability, clinical excellence, and employee development.
- Lead the development of a novel medical device platform from concept to commercialization.
- Build and scale the product development team, including hiring and mentoring top talent.
- Define and execute a long-term product road-map aligned with strategic business goals.
- Oversee all phases of development: concept, feasibility, design, V&V, and transfer to manufacturing.
- Ensure compliance with global regulatory standards (FDA, ISO 13485, EU MDR).
- Collaborate with cross-functional teams including Regulatory, Clinical, Quality, and Commercial.
- Drive innovation through technology scouting, IP strategy, and external partnerships.
- Manage budgets, timelines, and resources across multiple development programs.
- 8+ years of experience in medical device product development, with 4+ years in leadership.
- Proven success launching Class II or III devices and scaling development operations.
- Strong understanding of design controls, risk management, and product lifecycle.
- Experience with regulatory submissions (510(k), PMA, CE Mark) and documentation (DHF, IQ/OQ/PQ).
- Bachelor's degree in Engineering or Biomedical Sciences (Master's or PhD preferred).
- Excellent leadership, strategic thinking, and collaboration skills.
- Built or scaled product development teams or facilities.
- Familiarity with Lean Product Development or Agile methodologies.
- Involvement in strategic planning, M&A, or innovation initiatives.
- Direct support from senior leadership ensures resources and visibility.
- Define the future of a product line with global reach and clinical significance.
- Clear path to long-term leadership within a top-tier medtech company.