Medical Device Tooling & NPI Project Manager

5S Recruitment Limited; England; On-site; GBP 40,000 - 45,000; Full time

Job summary

5S Recruitment Limited is seeking a Project Engineer to lead medical device tooling and injection moulding initiatives in a regulated environment. Based in Cheshire, you will guide projects from handover to production release, coordinating cross-functional teams and ensuring regulatory compliance.

The role requires experience in medical device project management, strong communication, and the ability to manage multiple projects within strict timelines.

Qualifications

• 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.

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 elevate 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

Skills

Medical device project management

ISO 13485 experience

Stakeholder management

Multi-project leadership

Tools

Injection moulding tooling exposure

Job description

5S Recruitment Limited is seeking a Project Engineer to lead medical device tooling and injection moulding initiatives in a regulated environment. Based in Cheshire, you will guide projects from handover to production release, coordinating cross-functional teams and ensuring regulatory compliance.

The role requires experience in medical device project management, strong communication, and the ability to manage multiple projects within strict timelines.