Project Manager

Location: Cambridge, MA Salary: $140,000.00 USD Annually - $160,000.00 USD Annually Description:
Project Manager, Medical Device Development

Location: Charleston, SC, Cambridge, MA or Deerfield Beach, FL

Employment Type: Full-Time

Contact: Email resume to David Kellogg, Judge Group Sr. Recruiter at

About the Role

We are seeking an experienced Project Manager, Medical Device Development to lead complex product development programs from concept through commercialization. This role is responsible for driving cross-functional teams, managing project scope, schedules, budgets, risks, and resources, and ensuring successful execution within a highly regulated medical device environment.

The ideal candidate will have a proven track record leading multidisciplinary medical device development projects and collaborating with engineering, quality, regulatory, manufacturing, and customer stakeholders. This individual will serve as the central point of coordination throughout the development lifecycle, ensuring projects are delivered on time, within budget, and in compliance with quality and regulatory requirements.

Key Responsibilities

• Lead the planning and execution of complex medical device development programs from concept through product launch.
• Manage project scope, schedules, budgets, resources, and deliverables to meet business and customer objectives.
• Coordinate cross-functional teams including Mechanical Engineering, Electrical Engineering, Software, Quality, Regulatory Affairs, Manufacturing, and Supply Chain.
• Serve as the primary liaison between customers, stakeholders, and internal teams throughout the product development lifecycle.
• Gather and translate customer requirements, user needs, and Voice of the Customer (VOC) inputs into actionable project plans.
• Develop and maintain detailed project schedules, milestones, resource plans, and execution strategies.
• Forecast staffing and resource requirements to ensure successful project delivery.
• Monitor project performance and drive corrective actions to address schedule, budget, or technical challenges.
• Identify, assess, and mitigate project risks while escalating critical issues when necessary.
• Manage project changes, including scope, timeline, and budget adjustments, while maintaining stakeholder alignment.
• Facilitate regular project reviews, status meetings, and executive updates.
• Coordinate activities with external vendors, suppliers, and development partners.
• Ensure adherence to medical device design controls, quality systems, and regulatory requirements.
• Communicate project progress, key decisions, and risks to leadership, stakeholders, and customers.

Required Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• 5+ years of project management experience within a regulated product development environment.
• Experience leading cross-functional teams and managing complex technical projects.
• Strong understanding of project management methodologies, tools, and best practices.
• Knowledge of medical device product development processes and design controls.
• Experience with project planning, scheduling, budgeting, resource management, and risk management.
• Strong stakeholder management and communication skills.
• Ability to influence decision-making and align diverse teams toward common objectives.
• Experience working within FDA-regulated, ISO 13485, GMP, or other regulated environments.

Preferred Qualifications

• PMP (Project Management Professional) certification.
• Experience managing Class I, II, or III medical device development programs.
• Strong understanding of Human-Centered Design (HCD) and usability engineering principles.
• Experience supporting product development from concept through commercialization.
• Familiarity with manufacturing processes including injection molding, machining, tooling, and rapid prototyping.
• Experience working with contract manufacturers, suppliers, and external development partners.
• Knowledge of change management and continuous improvement methodologies.

Desired Skills

• Medical Device Development
• Project Planning & Execution
• Budget & Cost Management
• Resource Planning
• Risk Management
• Schedule Management
• Design Controls
• Product Development Lifecycle Management
• Regulatory Compliance
• Stakeholder Management
• Cross-Functional Leadership
• Vendor & Supplier Management
• Change Management
• Problem Solving & Decision Making
• Customer Relationship Management

What Makes You Successful

• You excel at managing multiple priorities in a fast-paced development environment.
• You build strong relationships with customers and stakeholders.
• You communicate effectively across technical and non-technical teams.
• You proactively identify risks and drive solutions before issues impact project performance.
• You thrive in collaborative environments and enjoy leading teams toward successful product launches.

Language Requirements

• Fluent in English (written and verbal)

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