Instrument Development Engineer
Quotient
Edinburgh, United Kingdom
5d ago

Job Description

The Instrument Development Engineer is responsible for understanding the Assay workflow requirements for integration onto the MosaiQTM instrument.

The main responsibilities will include :

  • Interpret the assay needs and develop associated design inputs for the Instrument.
  • Support instrument development, assay integration and validation & verification activities.
  • Collaborate with all internal functional stakeholders, to ensure solutions developed meet the commercial, regulatory and functional performance needs, defined as product requirements.
  • Provide technical project management to ensure development solutions meet the internal stakeholder needs.
  • Participate in Design Reviews to ensure key milestone deliverables are achieved.
  • Lead and support Risk Management activities, including FMEA’s, to ensure robust and reliable designs.
  • Lead, develop and implement design characterisation, DOE’s and design verification strategies for efficient.
  • Complete and robust testing through report completion and anomaly resolution or independently perform tolerance, error budget or other design analysis by extending or adapting existing methodologies.
  • Clear understanding of medical device regulations including ISO, FDA GMP and design controls.
  • Clearly understand Risk Management; use Risk Management tools and techniques to develop solutions.
  • Qualifications

  • Degree in Bio Mechanical Engineering / Electrical or Electromechanical Engineering
  • Significant level of applicable industry experience is required
  • Strong experience in development of complex, sophisticated, software controlled electromechanical medical devices / IVD Instruments
  • Must be very capable of communicating in a clear and concise manner, independent and innovative thinker with excellent presentation and report writing skills
  • Additional Information

  • Fluent in English, German is a distinct advantage
  • Flexibility to travel up to 50% of time. Some travel is on short notice
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