Systems Engineer

Systems Engineer

You will also drive quality improvements and offer creative solutions to technical challenges.

• Manage all technical components of the platform and cartridges, including firmware, software, and system interfaces.
• Provide system-level technical guidance to ensure alignment across hardware and component teams.
• Analyse existing system architecture and suggest improvements or upgrades.
• Oversee new hardware development and manage the product development pipeline.
• Define and support verification testing, including protocol creation and analysis.
• Prepare documentation and assist with regulatory approvals.
• Identify new opportunities and solutions for enhancing the platform.
• Track the reliability and performance of the system.
• Guide software development requirements for the platform.
• Help manage security processes, including risk analysis and related documentation for integrated systems.
• Work with the R&D team to improve existing products and streamline development processes.
• Lead troubleshooting efforts, conduct root cause analysis, and develop corrective actions.

• Bachelor's degree in Clinical Engineering, Biomedical Engineering, Systems Engineering, or a related field.
• At least 10 years of experience in healthcare or molecular engineering, with expertise in FDA QSR and ISO 13485 standards.
• Proven experience in developing IVD diagnostic products, including statistical analysis for experimental design.
• Strong understanding of mechanical, electronic, and software design principles.
• Knowledge of molecular biology, especially PCR and sample preparation techniques.
• Strong leadership in managing engineering projects and teams.
• Ability to solve complex technical issues and system problems.
• Familiarity with clinical system architecture for medical device interoperability.

To be considered for this opportunity you will need to have the right to work in the UK.