Project Manager

Project Engineer Location: Cheshire Salary: £40,000 - £45,000 Depending on Experience Job Type: Permanent Industry: Medical Devices / Injection Moulding / Tooling / Manufacturing 5S Recruitment are working with a highly respected and growing medical device manufacturer seeking an experienced Project Manager (Medical Device Tooling & Injection Moulding) to join their expanding technical and NPI team. This is an excellent opportunity for a technically strong Project Manager (Medical Device Tooling & Injection Moulding) to manage complex tooling and NPI programmes within a regulated ISO 13485 manufacturing environment. The successful candidate will play a key role in delivering medical device tooling projects from customer handover through to full serial production release. The business operates within a fast-paced, highly regulated manufacturing environment and is seeking a Project Manager (Medical Device Tooling & Injection Moulding) with strong communication, planning and cross-functional coordination experience. Key responsibilities

• Manage medical device tooling and injection moulding projects from handover through to production release
• Develop and maintain project plans, timelines and milestone trackers
• Coordinate tooling, metrology, process engineering, quality, operations and supply chain activities
• Lead project meetings, technical reviews and customer updates
• Coordinate tooling manufacture, tool trials, steel-safe reviews and process optimisation activities
• Support IQ/OQ/PQ and PPQ validation activities
• Support FAI activities and process capability studies
• Manage project risk registers and escalate issues where required
• Ensure all changes are controlled through formal change management processes
• Maintain accurate project documentation and audit-ready records
• Act as the primary customer contact throughout assigned programmes
• Support internal, customer and regulatory audits where required

Requirements

• Previous experience within medical device project management
• Strong understanding of ISO 13485 regulated manufacturing environments
• Injection moulding and/or tooling exposure
• Experience managing tooling development and NPI programmes
• Strong communication and stakeholder management skills
• Experience supporting validation activities including IQ/OQ/PQ
• Ability to manage multiple projects simultaneously within demanding timelines

Desirable

• Engineering or manufacturing qualification
• Experience within clean room or regulated manufacturing environments
• Knowledge of medical device validation and compliance processes

What’s on offer

• Long-term opportunity within a growing medical device manufacturer
• Technically interesting tooling and NPI projects
• Stable and supportive engineering environment
• Opportunity to work across tooling, injection moulding, validation and customer-facing project activities
• Competitive salary and benefits package

About 5S Recruitment Limited 5S Recruitment Limited are a specialist engineering and manufacturing recruiter with over 16 years of plastics and injection moulding recruitment experience across the UK. We work closely with manufacturers across injection moulding, tooling, quality, maintenance and technical operations, offering a quality-over-quantity approach built around long-term relationships and industry knowledge