Salary: £40,000 – £46,000
Location: Stockton-on-Tees
Benefits:
* Competitive benefits package
* Ongoing training and professional development
* Supportive, engineering-led working environment
* Opportunity to work on complex NPI and validation projects
* Long-term career progression
The Company:
Theo James Recruitment is proud to be supporting an established medical manufacturing business in Stockton, recognised for its focus on quality, innovation and engineering excellence.
Operating within a highly regulated manufacturing environment, the company delivers technically demanding projects where product quality, process validation and compliance are essential.
This is an excellent opportunity to join a growing engineering team, working on New Product Introduction (NPI), validation and continuous improvement projects.
Job Description:
As a Project Engineer, you will play a key role in delivering NPI and engineering projects, with a particular focus on process validation, PPAP documentation and ensuring manufacturing processes meet customer and quality requirements.
You will support projects from initial RFQ and feasibility through development, validation, customer approval and handover into production.
Working closely with Engineering, Quality, Operations and customers, you will ensure new products and manufacturing processes are properly documented, validated and ready for production within a regulated environment.
Key responsibilities include:
* Lead and support process validation activities, including the preparation and execution of validation plans, protocols and reports.
* Prepare, coordinate and maintain PPAP documentation and customer-specific approval submissions.
* Develop and maintain Process Flow Diagrams, FMEAs and supporting quality documentation.
* Ensure engineering projects comply with internal quality procedures, customer specifications and applicable regulatory requirements.
* Support NPI projects from feasibility and RFQ through to validation, pre-production and manufacturing handover.
* Work closely with Quality and Production teams to identify process risks, resolve technical issues and implement corrective actions.
* Maintain accurate engineering records, Bills of Materials (BOMs), specifications and project documentation.
* Coordinate project activities to achieve agreed quality, cost and delivery targets.
Skills & Experience:
* Previous experience in a Project Engineer, Manufacturing Engineer, Process Engineer or Validation Engineer role.
* Strong understanding of process validation and manufacturing quality requirements.
* Experience preparing or supporting PPAP submissions, FMEAs and process documentation.
* Background working within a regulated or highly controlled manufacturing environment, such as medical devices, automotive, aerospace or pharmaceutical manufacturing.
* Experience supporting NPI, process development or manufacturing transfer projects.
* Ability to interpret engineering drawings, technical specifications and customer requirements.
* Strong documentation skills with an understanding of traceability, quality compliance and controlled engineering processes.
* Engineering degree or relevant technical qualification preferred.
* Strong communication skills with the ability to work across Engineering, Quality and Operations teams.
This position would particularly suit an engineer who enjoys the technical and quality aspects of project delivery, with experience ensuring new manufacturing processes are robust, validated and compliant before entering production.
If you have experience in validation, PPAP or NPI within a regulated manufacturing environment and are looking for your next opportunity in Stockton, we would be keen to hear from you
Salary description
£40000.00 - £46000.00 per year