Project Lead - Tooling & Injection Moulding

• Preparation and maintenance of detailed risk analysis
• CCR preparation, submission, documentation and maintenance
• Responsible for preparing, presenting and financial accuracy of the CAR (investment application)
• Integration support in cooperation with Development department and Quality department.
• Continuous follow-up on implementation plans made (deadlines, resources, finances).
• Detailed overview, analysis, approach and timelines reported to Portfolio Manger
• Regular team meetings driven using PPM project theory
• Producing clear and concise financial statements, spending forecasts
• Leading communication with project team members to allow the Project Group to function as smoothly as possible.
• Coordinate tool design and manufacturing with internal teams and external mould makers to meet medical-grade specifications.
• 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 (e.g., ISO 13485, FDA).
• 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.

• 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 skills, especially in coordinating with toolmakers and material suppliers.
• Cross-functional leadership, working effectively with engineering, quality, procurement, and regulatory teams.
• Problem-solving and decision-making abilities under tight timelines and high compliance standards.
• Excellent communication and documentation skills for reporting, audits, and stakeholder updates.
• Continuous improvement mindset, with experience in lean manufacturing or Six Sigma being a plus.

• Bachelor’s degree in engineering, manufacturing, or a related technical discipline (mechanical, plastics, or biomedical engineering preferred).
• Project management certification such as PMP or PRINCE2 is highly desirable.
• In-depth knowledge of injection mould toolmaking processes and materials.
• Familiarity with medical device regulations, including ISO 13485, FDA 21 CFR Part 820, and validation protocols.
• Proficiency in CAD software and mould flow analysis tools is a plus.
• Strong understanding of supply chain and vendor management, especially in regulated environments.
• Excellent communication and leadership skills, with a track record of cross-functional collaboration.

• The position may involve travel up to 20%, both domestically and overseas. Most trips will include overnight travel.

• This role may be based in Michalovce with an onsite working structure.

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