Project Manager (Medical Device Tooling & Injection Moulding) Location : Warrington, WA3 Salary : £35k-£45k DOE Overview We are seeking a highly skilled and organised Project Manager to oversee and deliver complex projects within our client's organisation. The ideal candidate will be responsible for the controlled execution of medical device tooling and NPI programmes from customer handover through tooling development, process development, validation, and release to serial production. The role ensures projects are delivered on time, to cost, and to defined quality and regulatory requirements in compliance with ISO 13485. Key Responsibilities Manage assigned projects from customer handover through to production release Develop, maintain, and control project plans, milestones, and schedules Ensure adherence to approved NPI phase-gate processes Coordinate internal teams including tooling, process development, metrology, quality, operations, and supply chain Lead project meetings and technical reviews Maintain project risk registers Identify, assess, manage, and escalate technical, quality, cost, and schedule risks Oversee tooling design reviews, manufacture, trials, and steel tuning Support process development and optimisation activities Coordinate IQ/OQ/PQ or PPQ validation activities Support FAI and capability studies Ensure all validation and approvals are completed prior to production release Ensure project changes are formally assessed, approved, and documented Maintain configuration control of drawings and specifications Act as the primary customer contact for assigned programmes Provide regular status updates, milestone tracking, and reporting Maintain accurate and complete project documentation Ensure objective evidence is available for internal, customer, and regulatory audits Support audit activities as required Proactively drive issue resolution and escalate where necessary Skills, Experience & Qualifications Essential Proven experience managing projects within the medical device industry Strong working knowledge of ISO 13485 Exposure to injection moulding and/or tooling environments Excellent planning, organisational, and communication skills Desirable Engineering or manufacturing-related qualification Experience working within regulated manufacturing environments What's on Offer A technically challenging role within a regulated medical device environment Opportunities to work on end-to-end NPI programmes Collaborative cross-functional working environment Support for professional development If you are a confident Project Manager with experience in medical devices, tooling, or injection moulding and are looking for your next challenge, wed love to hear from you! Benefits: Company pension Free parking On-site gym On-site parking