Project Manager – Medical Device Development

1. General Information

Job Title: Project Manager
Department: Project Management
Reports To: Director of Project Management
Location: United States
Employment Classification: To be determined

2. Job Overview

Our client is seeking a Project Manager to oversee the successful execution of complex projects within a highly regulated medical device manufacturing environment.

This individual will work closely with cross-functional teams to ensure project requirements, schedules, budgets, and deliverables remain on track. Responsibilities include project planning, resource allocation, financial oversight, risk management, and project team leadership.

The Project Manager will lead multidisciplinary teams through complex mechanical medical device and equipment development initiatives, ensuring successful execution under GMP and applicable regulatory requirements.

The role requires strong communication with customers, internal stakeholders, and functional leaders throughout the design and development lifecycle.

3. Key Responsibilities

• Lead projects involving the design and development of complex mechanical medical devices and equipment.

• Maintain oversight across engineering and other functional disciplines, ensuring alignment with customer objectives, project deliverables, and individual responsibilities.

• Incorporate Voice of the Customer (VOC) requirements and user needs into project planning and execution.

• Collaborate with customers, internal stakeholders, and cross-functional teams throughout project initiation, design, and development.

• Define project scope, objectives, deliverables, and milestones in collaboration with project sponsors, program managers, and product managers.

• Forecast resource requirements, assemble appropriate project teams, and ensure team members have the necessary resources and expertise.

• Develop and manage project budgets, monitor costs, and maintain financial accountability.

• Establish detailed project schedules, work plans, and execution strategies.

• Coordinate internal resources and external vendors to support successful project execution.

• Monitor project performance, identify improvement opportunities, and implement corrective actions.

• Identify, assess, and mitigate project risks, escalating critical issues when necessary.

• Manage changes to project scope, schedules, and budgets while communicating impacts to relevant stakeholders.

• Organize and lead project meetings to review progress, address challenges, and coordinate next steps.

• Provide regular updates to stakeholders regarding project milestones, deliverables, schedule adjustments, and overall performance.

4. Required Qualifications

• Understanding of human-centered industrial design, usability research, and their integration with engineering and product development.

• Strong knowledge of project management methodologies, processes, tools, and best practices.

• Advanced time management, organizational, and risk management skills.

• Demonstrated ability to lead cross-functional teams and encourage collaboration toward shared objectives.

• Strong communication, stakeholder management, and decision-influencing skills.

• Bachelor's degree in Engineering or an equivalent qualification.

• Proficiency in English.

5. Preferred Qualifications

• Project Management Professional (PMP) certification.

• Approximately 5+ years of project management experience.

• Experience managing projects involving mechanical medical devices or complex manufactured products.

• Familiarity with manufacturing processes, including plastic injection molding, machining, and rapid prototyping.

• Knowledge of performance evaluation, change management, and continuous improvement principles.

• Experience coordinating multidisciplinary engineering teams within regulated or GMP manufacturing environments.

6. Additional Information

This position requires the ability to manage multiple stakeholders, adapt to evolving project requirements, and drive complex development initiatives from initiation through successful completion.

Responsibilities may evolve based on organizational needs and project requirements.