Design Engineer- Devices (GMP)

Location
Cambridgeshire (GB)
Salary
Competitive salary + benefits
Posted
25 May 2021
Closes
24 Jun 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)


Responsibilities:

  • Working w thin design teams to develop drug delivery systems, you will apply your technical and creative skills to engineering and design-related challenges, to meet evolving industry standards, regulatory and user requirements.
  • Driving your design with solid engineering principles, you will carry out in-depth calculations and tolerance analysis to evaluate technical risks to ensure the design is robust. Where issues arise, you will devise effective mitigations with supporting rationale to help keep the project on track.
  • Writing technical reports and producing high quality design documentation within a regulatory controlled GMP environment. You will apply your knowledge of materials, manufacturing processes, finishing and assembly to develop cost-effective and robust devices. With a combination of research and networking, you will build up a greater awareness and understanding of real-world manufacturing processes.
  • Liaising with external partners/suppliers and others in the GDD Project Team lo support industrialisation, scale-up and verification of device design and to ensure an integrated approach to overall project delivery.


Qualifications:

  • Bachelors degree in mechanical engineering or a related discipline.
  • Fluent with 3D CAD; Creo and/or Solidworks
  • Knowledge of manufacturing and assembly processes and the key drivers for high volume manufacture, with experience (ideally) in plastic injection moulding.
  • Must possess mechanical creativity, insight and attention to detail applied to the creation of reliable mass-produced devices.
  • Track record of having produced high-qualify design in advanced mechanical product development projects.
  • Awareness of the principles of Design Control, as these will underpin your work within our quality management system, accredited to ISO 13485 & FDA 21 CFR Part 820.
  • Highly driven and motivated person. Good communication skills are essential as an important part of your role will be communicating your work to team members and colleagues.
  • International travel well be required as part of this role, when restrictions ease.

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