Project Manager – Medical Devices

ChromoLogic • Monrovia, CA

6d

About The Position

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

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees