In brief
This permanent project manager role oversees tooling and NPI programmes for a medical device manufacturer. The work involves coordinating cross-functional teams, managing project timelines, and ensuring all technical activities meet strict ISO 13485 regulatory standards.
Best for
Project managers with experience in medical device tooling and injection moulding.
Non-negotiable
Previous experience within medical device project management required.
What you need
Required
Medical device project management
Clearly required in the listing
ISO 13485 compliance
Clearly required in the listing
Injection moulding
Clearly required in the listing
Tooling development
Clearly required in the listing
NPI programme management
Clearly required in the listing
Communication
Clearly required in the listing
Stakeholder management
Clearly required in the listing
Validation activities
Clearly required in the listing
Preferred
Engineering qualification
Clearly required in the listing
Clean room experience
Clearly required in the listing
Your day-to-day
Manage tooling and NPI projects
Clearly stated in the job description.
Develop project plans
Clearly stated in the job description.
Coordinate cross-functional activities
Clearly stated in the job description.
Lead technical reviews
Clearly stated in the job description.
Support validation activities
Clearly stated in the job description.
Manage project documentation
Clearly stated in the job description.
Act as customer contact
Clearly stated in the job description.
Experience expected
Level
Not stated
Based on what the listing states
Years of experience
16 years
of relevant experience stated for this role
Clearly stated in the listing
Evidence from the listing
Years required
“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 Coo…”
Full job description (from employer)⌄
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
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