About the job
QuantuMDx is looking for an enthusiastic and motivated candidate to join our systems integration team, with a focus on further developing our Q-POCTM platform and associated diagnostic tests. A relevant engineering background and/or a good understanding of science and physics would be beneficial, as the role will help to integrate various aspects of our product design and R&D activities, working with multiple teams across biological, assay feasibility, mechanical/electronic/software engineering, and production/manufacturing.
Key Roles & Responsibilities
Performing a combination, but not necessarily all, of the following duties:
- Help to guide technical design/solutions to further develop our diagnostic platform
- Participate in Technical design review and risk management meetings
- Developing technical requirements and communicating with assay, manufacturing, software, electronics, and mechanical teams
- Communicating with external research and manufacturing partners
- Work towards the goals of collaborative projects with external partners and be point of contact for some
- Generate, record and present complex information, to line manager, colleagues, senior management, and external partners
- Investigate integration issues and report findings
- Write scientific plans and reports, SOPs, Risk assessments
- Manipulate and analyse datasets
- Keep up to date with relevant regulations and relevant safety standards for Point-of-Care In-vitro diagnostics devices
- Contribute to maintaining high documentation standards in our ISO 13485 Quality Management System (QMS)
Experience, knowledge, and requirements
- Good academic understanding of Engineering/Science to a degree level
- Ability to work in diverse multidisciplinary teams
- Commitment to work within the Company’s Quality Systems and Policies
- Good work ethic and strong communication skills
- Ability to learn new techniques and technologies
- Understanding of scientific process and design of experiments
- Basic understanding of statistical/data analysis, and how to present results
- Ability to produce high quality documentation/reports
- Be eligible to work full time in the UK without restriction
- Good sense of humour and ability to work in a changing environment on complex projects
- Knowledge and experience of statistics and data analysis tools and techniques
- Relevant experience in areas such as product development, medical/diagnostic devices, technology development
- Demonstrated ability to lead collaborative projects with external partners
- Previous experience in the verification and validation of medical devices
- Knowledge of regulatory standards such as EN61010, or EN60601
- Knowledge of software languages e.g Python, C, C#, VB
QuantuMDx is a progressive MedTech company passionate about empowering the world to control disease and reduce suffering. QuantuMDx solves real-world diagnostic problems by creating multiplex molecular solutions for the Point of Need, for anyone, anywhere. QuantuMDx has global operations and strategic partnerships – keeping it at the forefront of molecular diagnostics.
The Q-POC™ platform is a rapid, simple to use, portable, sample to answer multiplex PCR device. It has been designed for use in a range of real-world settings, such as hospitals, clinics, pharmacies, dentistry, workplaces and in the field, providing accurate PCR results at the Point of Need.
Q-POC™ and its first test, a SARS-CoV-2 multiplex detection assay, are CE-IVD marked under the In Vitro Diagnostics Directive (98/79/EC), enabling use within Europe. It tests multiple targets of the disease for a future proof COVID-19 testing solution at the Point of Need.
QuantuMDx plans to launch a range of syndromic multiplex testing assays over the coming months and years.
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The intent of this job description is to provide a representation and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.