Project Lead - Tooling & Injection Moulding

About the Role

The role entails day-to-day management of tooling projects, ensuring timely delivery, quality, and regulatory compliance of injection moulding tools that support life-enhancing therapies for chronic conditions such as diabetes and Parkinson’s disease. You will work closely with internal teams and external mould makers to meet medical-grade specifications, manage timelines and budgets for tool development, and oversee validation and qualification of injection moulds in compliance with medical device standards.

What You Will Do

• Prepare and maintain detailed risk analysis and CCR preparation, submission, documentation, and maintenance
• Prepare, present, and ensure financial accuracy of the CAR (investment application)
• Provide integration support in cooperation with the Development department and Quality department
• Continuously follow up on implementation plans, including deadlines, resources, and finances
• Produce clear and concise financial statements and spending forecasts
• Lead communication with project team members to ensure smooth project execution
• Coordinate tool design and manufacturing with internal teams and external mould makers
• Manage timelines and budgets for tool development, ensuring on-time delivery and cost control
• Oversee validation and qualification of injection moulds in compliance with medical device standards
• Ensure supply chain readiness, including sourcing materials, managing vendors, and planning for production ramp-up
• Facilitate cross-functional communication between engineering, quality, procurement, and regulatory teams
• Mitigate risks and resolve issues during tool fabrication, testing, and production transfer
• Maintain documentation and traceability for audits and regulatory submissions
• Drive continuous improvement in tooling performance, cost efficiency, and supplier capabilities

What We Are Looking For

• 5+ years of experience in project management within injection moulding or medical device manufacturing
• Strong technical knowledge of injection moulding processes, tool design, and manufacturing workflows
• Experience in medical device development, including familiarity with ISO 13485, FDA regulations, and validation protocols
• Project management expertise, including scheduling, budgeting, and risk mitigation across complex, multi-phase projects
• Supplier and vendor management experience
• Strong communication and leadership skills
• Ability to work in a fast-paced environment and drive continuous improvement
• Proficiency in Excel and other project management tools

Nice to Have

• Experience with PPM project theory and methodologies
• Knowledge of medical device standards and regulations, including ISO 13485 and FDA
• Familiarity with quality management systems and audit procedures
• Certification in project management, such as PMP or Prince2

Benefits and Perks

• Competitive salary and benefits package
• Opportunity to work on high-impact projects that improve the lives of patients worldwide
• Collaborative and dynamic work environment
• Professional development and growth opportunities
• Remote work arrangements and flexible working hours
• Access to cutting-edge technology and tools
• Comprehensive health insurance and wellness programs

• Develop a strong understanding of injection moulding processes and tool design to stand out as a candidate
• Showcase your experience in medical device development, including familiarity with ISO 13485 and FDA regulations
• Highlight your project management skills, including scheduling, budgeting, and risk mitigation
• Be prepared to provide specific examples of your experience in supplier and vendor management
• Emphasize your ability to work in a fast-paced environment and drive continuous improvement
• Familiarize yourself with Convatec's products and mission to demonstrate your passion for the industry