Project Manager – Medical Devices

About Us

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. This role is critical to keeping projects on track in a fast-paced, resource-lean environment while ensuring compliance with FDA design controls and quality system requirements
.

The ideal candidate has 4–10 years of experience managing medical device development programs, has successfully supported new product launches
, and is comfortable wearing multiple hats in a startup setting.

Chromo Logic LLC () is a world-class innovation center with advanced scientific research and development in the medical, aerospace and security markets. Covisus Inc. () is a VC-funded spin-off from Chromo Logic that has developed an award-winning and industry-leading technology for tagless tracking of assets based on its vTag® technology.

• 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

• Bachelor’s degree in Bioengineering, Life Sciences, or a related technical field
• 4–10 years of project management experience in the medical device industry
• Demonstrated experience supporting new product development and U.S. product launches
• Strong working knowledge of FDA regulations
  , including:
  Design Controls (21 CFR 820.30), Risk Management (ISO 14971), and Quality System Regulation (21 CFR 820)
• Experience working closely with Regulatory and Quality teams on FDA submissions
• Proven ability to manage ambiguity and shifting priorities in a startup or small-company environment
• Excellent communication, organization, and problem-solving skills

• PMP certification or formal project management training
• Experience in an early-stage or venture-backed medical device startup
• Experience with first-of-kind or first-company FDA submissions
• Familiarity with contract manufacturers and external development partners

• Highly proactive and execution-focused
• Comfortable leading without formal authority
• Detail-oriented with strong systems thinking
• Resourceful and adaptable in a fast-moving environment
• Passion for building products that improve patient outcomes

• Competitive salary and benefits package, including stock options
• Opportunities for professional growth and development
• A collaborative and inclusive work culture
• The chance to work on cutting-edge technology projects that make a real-world impact