Project Manager, Medical Device

Project Manager – Medical Device Product Development

Lead innovative product development projects from concept through commercialization in a global medical device environment.

We are seeking an experienced and highly motivated Project Manager to lead cross-functional product development projects from initiation through successful product launch. This position offers an exciting opportunity to work with global engineering and R&D teams, drive innovation, and contribute to the development of high-quality medical devices that make a meaningful difference in healthcare.

The ideal candidate brings a strong background in medical device product development, excellent project management skills, and the ability to lead diverse teams across multiple disciplines and international locations. Success in this role requires a proactive, results-oriented professional who can manage complex projects, anticipate challenges, and keep teams aligned on priorities, timelines, budgets, and quality expectations.

Responsibilities

• Lead Product Development Projects: Manage complex medical device development projects from initial concept and business case through design, development, validation, and commercial launch.
• Drive Cross-Functional Collaboration: Coordinate global project teams across R&D, Engineering, Marketing, Operations, Supply Chain, Quality, and Regulatory Affairs to ensure alignment and successful execution.
• Manage Global Partnerships: Collaborate with internal teams and external development partners across the United States, Switzerland, and China, leveraging the expertise of each organization to achieve project objectives.
• Own Project Planning and Execution: Develop and manage project plans, milestones, budgets, resource requirements, deliverables, and launch schedules while maintaining accountability for project performance.
• Identify and Mitigate Risks: Proactively assess technical challenges, project dependencies, resource constraints, and potential delays. Develop solutions and escalate critical issues to maintain project momentum.
• Ensure Regulatory Compliance: Oversee project execution in accordance with medical device regulatory requirements, design controls, quality standards, and established product development processes.
• Support Technical Development: Partner with engineering and technical teams to incorporate risk management, FMEA, requirements engineering, and appropriate development methodologies throughout the product lifecycle.
• Lead Project Reviews and Communication: Facilitate project meetings, communicate progress to key stakeholders, prepare recommendations, and present project status and decisions to leadership.
• Maintain Documentation and Launch Readiness: Ensure complete and accurate project documentation, including technical files, and coordinate activities required for successful product launches.
• Champion Continuous Improvement: Introduce and reinforce project management processes, tools, and best practices that improve team effectiveness, project execution, and overall product development performance.

Qualifications

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Systems Engineering, Information Technology, Natural Sciences, or a related technical discipline. Preferred: Master's degree in Engineering, Science, Business Administration, or a related field.
• Project management certification or formal training, such as PMP or equivalent.
• Direct experience managing medical device development projects from concept through commercial launch.
• Minimum of 5 years of experience in product development, with demonstrated involvement in managing or coordinating complex development projects.
• Strong project management experience, including project planning, scheduling, budgeting, resource allocation, risk management, and stakeholder communication.
• Experience working in a highly regulated industry, preferably medical devices.
• Knowledge of product development lifecycles, design controls, R&D processes, and cross-functional engineering disciplines.
• Familiarity with FDA design controls, ISO 13485, risk management, FMEA, and medical device technical documentation.
• Understanding of manufacturing, industrialization, and supply chain considerations associated with bringing new products to market.
• Experience collaborating with cross-functional teams in a global or matrixed organization.
• Experience with structured product development processes, stage-gate methodologies, and project portfolio management tools.
• Strong communication, organizational, analytical, and problem-solving skills.
• Demonstrated ability to influence, motivate, and lead project teams without direct reporting authority.
• Travel: Up to 10% including occasional international travel.