Instrument Development & Validation Engineer

  • Eysins, Switzerland
  • Full-time

Company Description

Building on 30 years of experience in transfusion diagnostics, Quotient is a commercial stage
diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced.  Quotient has two key product portfolios, Alba by Quotient and MosaiQTM by Quotient. The Alba by Quotient product range is comprised of high-quality reagents used to keep laboratories around the world running efficiently. They are sold directly to laboratories or through our OEM partners. MosaiQ™ by Quotient is our proprietary multiplex microarray technology, offering the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. MosaiQ™ is designed to be a game-changing solution, which we believe will increase efficiencies, improve clinical practice, deliver significant workflow improvements and operational cost savings to laboratories around the world. Quotient’s operations are based in Eysins/Switzerland, Edinburgh/Scotland and Newtown/Pennsylvania.

Job Description

Quotient is recruiting for an Instrument Development & Validation Engineer to join the Systems Engineering team based in Eysins. The role is a full-time and permanent position.

The Instrument Development & Validation Engineer is responsible to understand the Assay workflow requirements for integration onto the MosaiQTM instrument, interpret the assay needs and develop associated design inputs for the Instrument.

The main responsibilities will include:

  • Understand Product assay workflow and associated Instrument design inputs;
  • Support successful Product life-cycle development with a specific focus on requirements engineering development, verification, validation and associated technical file construction;
  • Execution of scheduled activities to plan in compliance with existing internal policies and procedures;
  • Lead / Define / Support System DOE with respect to system characterisation efforts in development, verification and validation phase;
  • Support Risk Management activities to support a risk-based verification and validation philosophy;
  • Define, implement and ensure compliance with Standard Policies and Procedures for instrumentation and Quality Control;
  • Support internal complaint management process at instrument level;
  • Work directly with a third party partner to develop instrument solutions to meet the design input needs;
  • Provide technical project management to ensure development solutions meet the internal stakeholder needs;
  • Ensure all development activities are in compliance with regulatory requirements, ensuring adherence to life cycle requirements;
  • Participate in Design Reviews to ensure key milestone deliverables are achieved;
  • Support risk management activities, including FMEA’s, to ensure robust and reliable designs.

Qualifications

  • Degree in Biomedical Engineering / Software or Electromechanical Engineering;
  • Experience in development of complex, sophisticated, software controlled electromechanical medical devices / IVD Instruments;
  • Understanding of Medical Device Life Cycle processes, Requirements Definition and V&V activities;
  • Experience in documenting medical device requirements (design inputs) with accuracy and testing outputs to ensure inputs are achieved;
  • Strong report writing and presentation skills with excellent attention to detail;
  • Excellent time management and prioritisation skills;
  • Ability to self-motivate/Autonomous;
  • Excellent analytical approach to problem solving and troubleshooting;
  • English Proficient;
  • Occasional travel is expected.