Job Purpose:The Lead hardware Support Engineer is responsible for assisting with troubleshooting, testing, and investigation activities for our IVD instrumentation platform hardware as part of the System Integration Team. This will involve communication and collaboration with both hardware engineers and assay scientists.Scope of role:Member of the System Integration Team responsible for end-to-end delivery of the product support aspects of the instrumentation hardware, interfacing between the instrumentation and assay teams.Essential Experience:· Experience in scientific test method development and test automation· Proficient with test automation using Python, LabVIEW, MATLAB, or similar packages.· Experience in data processing of large sets of data, such as using Python for data manipulation and analysis.· Experience in using data analysis and visualization for driving investigations and reporting outcomes, such as Python, PowerBI.· Experience using one or more scripting or programming languages.· Data focused, able to use a variety of data sources to guide investigations.· Experience measuring and reporting quality related metrics.· Working knowledge of running systematic root cause analyses to address problems in complex systems.· Ability in running multiple project/ investigation· Working knowledge in using project management tools, such JIRA or MP· Working knowledge using JIRA and/or other tools for the implementation of Agile processes.· Confident speaking the language of assay scientists and instrumentation engineers.· Excellent oral and written communication skills with the ability to communicate clearly to upper management and other stakeholders.· Delegate tasks to other team members and follow up on their progressEssential Qualifications:· Working knowledge in the design & development of medical devices and / or support of medical device production.· Working knowledge in the development of IVD devices and / or support of IVD device production.· Working knowledge of optical and imaging system.· Working knowledge of electro-mechanical systems.· Working knowledge of microfluidic systems.· MSc degree in an engineering or science discipline.Responsibilities:· Be aware of project timelines and contribute actively to aligning the outcomes of investigations with other teams and the wider business.· Create robust characterisation and test methods to measure performance across a wide range of interacting sub-systems in a complex medical device.· Provide innovative analysis solutions to answer complex technical questions.· Review and critique analysis solutions developed by other team members.· Ensure that instrument and assay investigations are developed and implemented in a robust and rapid manner.· Creation of well-structured documentation, such as test protocols and reports, that comply with the company quality system.· Use of online tools for document management, task management and requirements management.· Ability to develop and execute test protocols as part of technical investigations and / or formal test programs.· Good appreciation for electronics, software, mechanical and optical engineering disciplines.· Hands-on knowledge in test automation platforms like LabVIEW, MATLAB and Python.· Use or develop competent knowledge in the required regulations applicable to the development of medical devices.· Work with QC, manufacturing transfer and contact manufacturers to address production problems.· Provide technical guidance for assay scientists by providing hands-on support to address instrumentation problems· Support engineers and assay scientists with the development of scripts for various investigations and experiments.· Ability to analyse large volumes of laboratory data, identifying any anomalies.· Proactively log bugs and provide feedback to appropriate design teams (electronics, software, mechanical, etc).Be integral part of bug / defect tracking meetings and make effective contributions to ensure end-to-end performance of the system.
