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A dynamic biotechnology development organisation, based south of Cambridge, are seeking an exceptional Senior Mechanical Design Engineer to work on medical device R&D projects.

The vacancy for a Senior Mechanical Engineer / Principal Mechanical Engineer would suit candidates with a solid background in the full product mechanical design for medical devices or similar scientific instruments. We would be very keen to seen experience of any of the following: Microfluidics, Diagnostics instruments, LoC (Lab on Chip), Systems on Chip, Blood analysis devices, Biomedical, DNA Analysis, genomic sequencing etc

Responsibilities Senior Mechanical Design Engineer

  • Development of complete mechanical and microfluidics projects for current and future instrument platforms.
  • Ownership of the whole mechanical system and subsystems used for sample preparation and analysis of biological materials incorporating microfluidics, fluidic handling, biochemistry, thermal sensing and control, electronics, optics and mechanical functional modules.
  • Platform development from requirement gathering, concept generation, design prototyping, design implementation, fabrication, test and integration.
  • Develop test strategies, perform risk analysis, troubleshoot interdisciplinary electromechanical and fluidics systems, identify root cause and implement corrective actions during the product development.
  • Develop the instrument and the development process through to volume production under relevant regulatory safety standards and directories.

Senior Mechanical Design Engineer required Qualifications, Experience

  • Degree (BSc/BEng/MEng/MSc/PhD) in mechanical engineering or biomedical engineering or similar with a minimum of 10 years relevant industry experience
  • Experienced in at least three of the following areas: control systems, system integration, mass flow and thermodynamics, microfluidics systems, injection moulding and/or optical systems
  • Highly competent in generating CAD based mechanical design drawings using Solidworks or similar mechanical design toolboxes and software packages.
  • Proficient with finite element modelling for precision applications such as fluidics systems and thermodynamic systems
  • Experience with the design, fabrication and test of complex and low-cost devices using biocompatible materials and injection moulding techniques, in both prototype quantities and full-scale manufacturing
  • Experience with experimental design, failure analysis and root cause analysis

Desirable

  • Experience with MEMS device fabrication and nanofabrication
  • Some knowledge of software programming and/or electronics design at system level
  • Knowledge and skills in process and product validation, particularly ISO 13485 and FDA QSR.

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