Systems Engineer

Systems Engineer

We are looking for a talented Systems Engineer to lead technical efforts for a busy medical device company. As a Systems Engineer, you will create innovative engineering solutions for both existing and new products. In this role, you will be responsible for evaluating and enhancing network technologies to improve connectivity, leading investigations, and supporting the integration of devices. You will also drive quality improvements and offer creative solutions to technical challenges.



Responsibilities

* 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.



About you

* 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