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| Job Location | Warwickshire |
| Education | Not Mentioned |
| Salary | Salary negotiable |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent, full-time |
The key responsibilities of this role are:* Review and approve existing requirements relating to all the clients disposables, amend and extend as necessary to deliver company goals* Collaborate with other team members to maintain and develop the clients disposable/machine sensing systems; through membrane pressure & temperature sensing, conductivity measurement, valve leak measurement, blood leak detection and air in blood detection* Oversee dialysate cartridge specification, design and testing, taking ownership of documentation and tasks as required* In conjunction with other team members, oversee extracorporeal circuit specification, design and testing, taking ownership of documentation and tasks as required.* Oversee verification and validation testing of all disposables and processes, both at our Clients and strategic manufacturing partner/s* Oversee disposables tooling and production equipment including design, procurement and commissioning* Review and define appropriate in line and end of line test procedures, definition according to production volume, risk reduction, process stability etc* Oversee IQ/OQ/PQ activities at strategic manufacturing partners* Identify off the shelf options for whole or part inclusion in our Clients dialysis bundle* Identify cost reduction opportunities from design and manufacturing including automation, process change, minor and major design change, volume etc* Develop strategies for disposables cost reduction appropriate to the companys scale up and volume manufacturing plans* Assume responsibility for design or manufacturing process Non Conformities and associated corrective actions* Work with strategic partners to realise volume scale up, product reliability and cost reduction programmes* Contribute to the development of our Clients in house processes including Quality, specification, development, verification & validationThe skills and competencies required include:* Knowledge of relevant manufacturing processes; injection moulding, hotplate welding, ultrasonic welding, solvent bending, sterilisation (EtO, Gamma, E beam)* Extensive manufacturing process development experience in a high volume environment* Manufacturing methods/process definition, validation, auditing and approval* Experience of automation strategy development and implementation* Strong analytical skills targeted at cost reduction, product quality, manufacturing scale up etc* Knowledge of 3D CAD (ideally Solidworks) so as to be able to interrogate parts and assemblies and make design recommendations* Experience of CAPA processes and issues management systems Required skills
Keyskills :
Healthcare Medical Devices Development Engineer Design Engineer Materials science; RD engineer; Disposables Engineer