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Industrialisation Engineer

Medical Devices

Cambridgeshire (£) Competitive
permanent Job Ref: 6397


Industrialisation Engineer

A leading medical device organisation is seeking an Industrialisation Engineer to join their Engineering team based in Cambridge. This is an excellent opportunity for an Industrialisation Engineer to develop and validate manufacturing processes in support of novel drug delivery technologies. Additionally as the Industrialisation Engineer you will provide input to the concept development of products for commercial manufacturing.

Industrialisation Engineer Responsibilities:

  • Provide contribution to device design concepts from a manufacturing perspective.
  • Support the development team during concept and detailed design phases by;
    • Developing proof-of-principle processes for key manufacturing steps
    • Leading development of scalable manufacturing processes and techniques
  • Procurement of capital process equipment and tooling for pilot-scale manufacture including;
    • Generation of GMP standard Requirements Specifications
    • Conducting supplier selection activities
    • Managing the relationship with suppliers during the build phase
  • Writing and executing GMP standard FAT SAT and IQ/OQ/PQ protocols (including mould tool validation)
  • Managing the technical transfer and operation of equipment at its final location
  • Compliance with regulatory requirements

Industrialisation Engineer Requirements:

· Experience working within injection moulding of polymers for complex precision products (medical devices electronic mechanisms mobile phones consumer goods)

· Knowledge of tooling design and DFM including multi-cavity systems

· Knowledge of automated assembly for plastic products

· Understanding of metrology and measuring techniques for precision products

· Knowledge and/or experience of drug product handling & filling operations for drug delivery devices

· Knowledge and/or experience of sterile liquid processing operations and techniques

· Validation activities including specification writing qualification testing and reporting

· Manage elements of technology transfer from component design into tooling and production

· Experience working under the ISO13485 and GMP quality systems

Role: Industrialisation Engineer
Package: Competitive Salary and Benefits
Hours: Mon-Fri
Sector: Manufacturing / Medical Devices / Pharmaceuticals
Location: Cambridge

Job Ref: 6397