Design and Development Engineer - Medical devices
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Location
Warwickshire
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Sector:
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Salary:
Negotiable
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Contact:
Chrissy Mitchell
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Contact email:
Chrissy.Mitchell@volt.eu.com
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Job ref:
76369-ENGIN-CML_1585125599
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Published:
3 dagen geleden
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Expiry date:
2020-04-24
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Startdate:
ASAP
* 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 company's 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 & validation
The 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