Description

As part of the Integrated MedTech (IMT) of the Diagnostics Development Hub (DxD Hub), you will collaborate with a team of Mechanical Design, Electronics, Firmware (Embedded Software) engineers to setup the right configuration for instruments developed for medical diagnostics.

Your role as Instrumentation Software Engineer is to understand the basic scientific principles involved in the processes at hand, and setup the right functions for the automated workflow, e.g. automated assay workflow in IVD product. You will thus assist in the selection of the electronic components based on the requirements of the processes, e.g. appropriate sensors and processors, and guide the firmware engineer in the programming of automation sequences and collection of required data for accurate analysis of the diagnostics, including baud rate, and work with the mechanical design engineer to achieve the right configuration for the various modules, e.g. optics, heater, microfluidics, etc. As follow-on, your software engineering role would then be to create the appropriate algorithm to select and process the collected data from the devised instruments into the positive and negative diagnostic test results, based on the operation principles of the instruments and the assay.

You may work with the Digital Diagnostics (DDx) Team at DxD Hub to bring these results to be connected to the cloud, and assist with AI integration when beneficial for the business case.

You will assist the product quality engineer in setting up appropriate quality gates during the development phases of the integrated medical devices, to establish the technical go/no-go milestones for the project. You will also contribute to the risk management of the integrated device from the instrumentation perspective according to ISO14971, in particular wrt the interactions between the various components and modules within the integrated diagnostics device.

Candidate Requirements

· At least 8 years of instrumentation & software development for associated algorithm, preferably in engineering of medical diagnostics.

· Demonstrated soft-skills to positively contribute in complex teams with people from various backgrounds and disciplines.

· Previous experience with medical device diagnostics development, including experience with quality management system based on ISO13485 for medical devices.

· Background in Mechatronics / Computer Engineering / Physics, or related fields.