Project Manager – Tooling, Injection Moulding

This is a fully remote position, open to applicants in Poland.

📋 Description

• Lead high-impact tooling initiatives essential for the development and supply of precision-moulded components used in advanced medical devices.

• Manage the entire project lifecycle, from initial concept through validation and production.

• Work collaboratively with cross-functional teams, including R&D, Quality, Regulatory, and Global Supply Chain.

• Facilitate supplier engagement, risk management, and ongoing improvement across a global tooling portfolio.

• Coordinate tool design and manufacturing with both internal teams and external mould makers to comply with medical-grade specifications.

• Oversee timelines and budgets for tool development, ensuring timely delivery and effective cost management.

• Supervise the validation and qualification of injection moulds in accordance with medical device standards (e.g., ISO 13485, FDA).

• Ensure supply chain readiness by sourcing materials, managing vendors, and planning for production ramp-up.

• Address risks and resolve challenges during tool fabrication, testing, and production transfer.

⛳️ Requirements

• 5+ years of experience in project management within the fields of injection moulding or medical device manufacturing.

• In-depth technical knowledge of injection moulding processes, tool design, and manufacturing workflows.

• Experience in medical device development, including a solid understanding of ISO 13485, FDA regulations, and validation protocols.

• Expertise in project management, encompassing scheduling, budgeting, and risk management for complex, multi-phase projects.

• Skills in supplier and vendor management, particularly in coordinating with toolmakers and material suppliers.

• Proven cross-functional leadership capabilities, effectively collaborating with engineering, quality, procurement, and regulatory teams.

• Strong problem-solving and decision-making skills under tight deadlines and stringent compliance requirements.

• Excellent communication and documentation abilities for reporting, audits, and stakeholder updates.

• A mindset focused on continuous improvement, with experience in lean manufacturing or Six Sigma being advantageous.

• Bachelor’s degree in engineering, manufacturing, or a related technical field (mechanical, plastics, or biomedical engineering preferred).

• Project management certification such as PMP or PRINCE2 is highly desirable.

• Proficiency in CAD software and mould flow analysis tools is a plus.

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off

• Professional development