Design and Development Engineer - Medical devices

  • Location

    Warwickshire, England

  • Sector:

    Bouw

  • Job type:

    Blijvend

  • Salary:

    Negotiable

  • Contact:

    Chrissy Mitchell

  • Contact email:

    Chrissy.Mitchell@volt.eu.com

  • Job ref:

    76369-ENGIN-CML_1585125599

  • Published:

    7 maanden geleden

  • Expiry date:

    2020-04-24

  • Startdate:

    ASAP

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 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