Instrument Development and Validation Engineer

Building on 30 years of experience in transfusion diagnostics, Quotient is committed to delivering solutions that reshape the way diagnostics is practiced.  Quotient has two key product portfolios, Alba by Quotient™ and MosaiQ™ 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. Quotient’s operations are based in Eysins, Switzerland, Edinburgh, Scotland and Chicago, Illinois.

INSTRUMENT DEVELOPMENT & VALIDATION ENGINEER

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

JOB PURPOSE

The Instrument Development and Validation Engineer will be working within the system R&D function on the MosaiQ instrument platform. The MosaiQ instrument platform is a multimodal, multiplex microarray system has been designed to design a broad spectrum of applications in the field of diagnostics including immunohematology, serology, autoimmune, allergy & molecular.

The Instrument Development and Validation Engineer will be presented with the unique opportunity to lead the continued development of the platform with respect to assay integration on the platform.

JOB DESCRIPTION

The Instrument Development and Validation Engineer will be responsible to record, analyse and reach valid conclusions for assay integration and characterization of instrument in consultation with assay R&D development team, enabling the completion of projects to the agreed timelines and the highest possible standard.

The Instrument Development and Validation Engineer will also be assisting in planning, organization, and execution of experimental studies, in the R&D department of Quotient.

The post holder will be part of dynamic team that drives innovation, lead or collaborate on key scientific and technical initiatives, and will be a key contributor to global launches of novel clinical in vitro diagnostic applications on the MosaiQ platform.

The main responsibilities include:

• Work in close relationship with R&D Assay development teams to ensure assay developed could be integrated into instrument
• Assist in the design, execution, and documentation of assay integration & characterization studies related to Research & Development projects: Immunohematology, disease screening, Autoimmune and Allergens in compliance with Design Control
• Understand Product assay workflow and associated Instrument design inputs.
• Be an expert of instrument, workflow, calibration & setup, service Software.
• Assist in developing plans for research projects or product development programs in conjunction with the project team: project tasks and milestones, timeline for project completion and resources/infrastructure required for the project.
• Analyse and interpret complex data produced in studies to evaluate the impact variabilities on the product characteristics.
• Maintaining accurate records of work and reporting data both internally and, if necessary, to other colleagues.
• Develop a clear understanding of the MosaiQTM Assay and its integration into the Hardware Instruments and Understand Product assay workflow and associated Instrument design inputs.
• Promoting beneficence and minimizing risks.
• Train staff in specific laboratory procedures to ensure that they are able to carry out the task independently according to local procedures.
• Prepare and review formal documentation (PPT, SOPs) in consultation with the Team Leaders and other staff where necessary to enable communication of the study
• Have a good working knowledge of IVD product requirements.
• Attend internal meetings and courses as appropriate and disseminate information to the development

QUALIFICATIONS & EXPERIENCE REQUIRED

• Primary Degree in Bio Mechanical Engineering / Software or Electromechanical Engineering.
• 3-5 years’ experience in development of complex, sophisticated, software controlled electromechanical medical devices / IVD Instruments
• Experience in Life science within a multi-disciplinary environment. Including bringing regulated products from Development through to commercial readiness
• Understanding of Medical Device / IVD Instrument Life Cycle.
• Strong working knowledge of Electromechanical Design, Requirements Definition and V&V activities.
• Excellent analytical approach to problem solving and troubleshooting.
• Clear, concise, effective communicator with diverse stakeholders at all organizational levels.
• Excellent presentation and report writing skills
• Strong organizational skills with proven ability to work in a multiple priority environment
• Proficiency in English, French or German an asset
• International travel may be required on demand