Director of Medical Products
San Francisco, CANew York, NYBoston, MAOnsite6+ YOE
Summary
Leads development of medical business leveraging sleep platform for condition detection and therapy, navigating FDA clearance, reimbursement, and commercialization with R&D teams. Requires 6+ years in medical devices with proven regulatory and launch success.
About the role
Responsibilities
- Build a medical business from 0 to 1
- Strategically navigate regulatory & reimbursement pathways
- Rapidly prototype and test business ideas
- Manage a cross-functional program involving R&D, Engineering, Regulatory, and Quality
- Coordinate with engineering teams to commercialize hardware and software products
Requirements
- 6+ years of industry experience in medical devices (hardware or SaMD)
- Successful track record of FDA clearance (510k, De Novo)
- Successfully launched a reimbursable medical device
- Exemplary at cross-functional program management
- Experience with product development
- Experience building a world class team
- Bachelor’s degree in engineering, business, or equivalent experience
Skills
Medical DevicesFDA 510kDe NovoRegulatory AffairsReimbursement PathwaysSaMDProduct DevelopmentCross-functional ManagementR&D CoordinationProgram Management