MECHANICAL SENIOR SYSTEM ENGINEER - MEDICAL DEVICE

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.

MECHANICAL SENIOR SYSTEM ENGINEER – MEDICAL DEVICE

Quotient is recruiting for a Mechanical Senior System Engineer to join the MosaiQ Engineering team. The role is a full-time and permanent position, based in Eysins, Switzerland.

JOB PURPOSE

The Senior Systems 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 transfusion and clinical diagnostics.

The candidate will be presented with the unique opportunity to lead the continued evolution of the platform with duties including development of new technology concepts and implementation into the system, leading the reliability growth plan for the MosaiQ system as well as supporting Assay integration into the system.

JOB DESCRIPTION

The Senior Systems Engineer will be responsible for identification of technology, development for integration into the Mosaiq system to improve the analytical performance of the system.

The candidate will lead the reliability growth plan for the instrument, performing pareto analysis of failure modes and driving the evolution of system both best in class MTBF, MTBI system performance.

Activities include characterization or root causing 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 candidate will also be assisting in planning, organisation, and execution of experimental studies, in the R&D department of Quotient.

The successful candidate will be part of dynamic team that drives innovation, leads or collaborates 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:

• Leads / Manages the lifecycle development of the MosaiQ instrument
• Work in close relationship with R&D Assay development teams and Instrument 3rd party supplier to ensure assays developed could be integrated into instrument in terms of workflow and Hardware requirements
• 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.
• Be an expert on complex instrumentation including expert knowledge on electro-mechanical, assay processing, optical detection systems, System Service Software.
• Lead cross-functional project teams as required to deliver product improvements as well as reliability program.
• Drive the third-party partner to deliver to project timelines and meet/or exceed key milestones.
• Lead and support risk management activities, including FMEA’s, to ensure robust and reliable designs
• Lead, develop and implement design characterization, 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.
• Ensure all development activities are in compliance with regulatory requirements, ensuring adherence to life cycle requirements.
• Design & test prototypes where required to support quick iterative development of Instrument
• Prepare and review formal documentation (PPT, SOPs) in consultation with the Team Leaders and other staff where necessary to enable communication of the study
• Assist in the design, execution, and documentation of assay integration & characterization studies related to Research & Development projects in compliance with Design Control
• Maintain accurate records of work and reporting data.
• Analyze and interpret complex data produced in studies to evaluate the impact variabilities on the product characteristics.
• Execute discrete studies in Laboratory environments.

QUALIFICATIONS & EXPERIENCE REQUIRED

• Primary Degree in Bio Mechanical Engineering / Electrical or Electro Mechanical Engineering.
• Minimum of 5 years’ experience in development of complex, sophisticated, software controlled electromechanical medical devices / IVD Instruments.
• Understanding of Medical Device / IVD Instrument Life Cycle.
• Strong working knowledge of Electromechanical Design, Requirements Definition and V&V activities.
• Deep expertise in one or more of the topics below (Mechanics, optics, Fluid dynamic, Image analysis)
• Clear, concise, effective communicator with diverse stakeholders at all organizational levels.
• Excellent presentation and report writing skills
• Excellent analytical approach to problem solving and troubleshooting.
• 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