Location: Cheshire
Salary: £35,000 - £40,000 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.

A well-established manufacturer of precision injection-moulded components and assembled devices is looking to recruit a Maintenance Engineer for its highly regulated South London manufacturing facility.

Operating within the medical, pharmaceutical and diagnostics sectors, the business runs approximately 60 injection moulding machines across white-room and classified cleanroom environments. This is a technically varied site combining high-volume moulding, robotics, bespoke automation and secondary assembly processes.

The Maintenance Engineer will work as part of the site engineering team, maintaining production equipment, responding to breakdowns and improving the reliability of machinery operating in a demanding 24/7 manufacturing environment.

The role will involve:

• Carrying out planned preventative maintenance across injection moulding machines, automation and associated plant.

• Responding quickly to electrical and mechanical breakdowns, identifying root causes and returning equipment to production safely.

• Maintaining injection moulding machinery, including hydraulic, pneumatic, electrical and mechanical systems.

• Supporting automated production cells incorporating linear robots, pick-and-place systems, conveyors and product-handling equipment.

• Working on secondary manufacturing equipment such as ultrasonic welding, laser-marking, camera-inspection, assembly and packing systems.

• Diagnosing faults involving motors, sensors, relays, contactors, inverters, temperature-control systems and PLC-controlled machinery.

• Maintaining auxiliary equipment including material-handling systems, dryers, chillers, compressors and vacuum systems.

• Completing planned maintenance records and ensuring engineering work meets the standards required within a regulated medical manufacturing environment.

• Supporting continuous improvement, machinery upgrades and reliability projects.

• Liaising closely with production, tooling and process teams to minimise downtime and recurring faults.

• Working safely within white-room and classified cleanroom production areas.

The site includes precision injection moulding machinery, KraussMaffei equipment, Wittmann robotic systems and bespoke automated assembly and inspection cells. The successful engineer will therefore need experience within a fast-moving automated manufacturing environment.

The Maintenance Engineer will ideally have:

• Previous experience as a Maintenance Engineer, Multi-Skilled Engineer or Maintenance Technician within manufacturing.

• A recognised electrical or mechanical engineering qualification.

• Strong electrical and mechanical fault-finding ability.

• Experience maintaining injection moulding machinery or other automated production equipment.

• Knowledge of hydraulics, pneumatics, motors, drives, sensors and control systems.

• The ability to fault-find on PLC-controlled equipment; programming experience is not essential.

• A methodical approach to breakdowns and root-cause investigation.

• Experience within plastics, medical devices, pharmaceutical manufacturing, packaging or another regulated environment would be advantageous.

This position would suit an engineer who enjoys genuine hands-on fault-finding and wants to work at a technically advanced manufacturing site where engineering standards, equipment reliability and product quality genuinely matter.

If you are an experienced Maintenance Engineer with a background in automated manufacturing, injection moulding or high-volume production, please apply with an up-to-date CV.

5S Recruitment is acting as an employment agency for this Maintenance Engineer vacancy.