Senior Systems Engineer
- Dublin, Ireland
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. MosaiQ™, Quotient’s proprietary multiplex microarray technology, offers 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 Quotient believes 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 Switzerland, Scotland and USA.
Quotient are recruiting for a Senior Systems Engineer to join the MosaiQTM Instrument Development team based in Dublin. This role entails working with all internal functional stakeholders, to ensure the solutions developed meet the commercial, regulatory and functional performance needs.
- Understanding the needs of product assay workflow and develop associated Instrument design inputs
- Working directly with a third-party partner to develop instrument solutions to meet the design input needs and ensuring they meet key milestones and timelines
- Leading project teams and providing technical project management to meet internal stakeholder needs
- Ensuring all development activities are in compliance with regulatory requirements, ensuring adherence to life cycle requirements
- Development and implementation of design characterization, DOE’s and design verification strategies
- Detailed understanding of medical device regulations including ISO, FDA GMP and design controls
- Primary degree in bio mechanical engineering / electrical or electro mechanical engineering
- Experience in medical device product development supported by relevant IVD business understanding
- strong working knowledge of electromechanical design, requirements definition and V&V activities.
- Manufacturing experience in a medical device / IVD manufacturing environment with specific emphasis on improvement methodologies
- Competitive salary & benefits package
- Flexibility to travel required, primarily in Europe. Travel requirements will vary but typically will be 20% of the time. Due to the nature of the role, some travel is at short notice.