Project Manager – Medical Devices

We are seeking a driven, hands-on Project Manager to lead cross-functional teams through the development and first-time commercialization of innovative medical devices.

Requirements

• Own end-to-end project management for medical device development from concept through FDA clearance/approval and U.S. launch
• Build and maintain integrated project plans, timelines, budgets, and resource plans in a startup environment with evolving priorities
• Lead cross-functional teams across R&D, Quality, Regulatory, Manufacturing, Supply Chain, and Clinical
• Drive execution of FDA-compliant development activities, including design controls, risk management, and design transfer
• Partner closely with the design teams to support FDA pre-submissions and submissions (e.g., 510(k), De Novo, PMA) and address FDA feedback
• Identify, assess, and proactively mitigate technical, regulatory, and operational risks
• Facilitate core team meetings, design reviews, and milestone/phase-gate reviews
• Track and clearly communicate project status, risks, and decisions to leadership and investors as needed
• Support early manufacturing scale-up, supplier readiness, and launch execution
• Help establish and improve project management tools, processes, and best practices as the company grows

Benefits

• Competitive salary
• Benefits package
• Stock options
• Opportunities for professional growth and development
• Collaborative and inclusive work culture