miDIAGNOSTICS

Near-Patient Diagnostic
Solutions

Globally shifting the way healthcare is managed for a wide range of diseases.

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The Ambition

Accurate and integrated diagnostic solutions that enable

faster and more efficient healthcare at any point of need.

miDiagnostics aims to bring clinical, blood-based diagnostics to the people who need it the most: the patients. Based around a disruptive silicon-based nanofluidic processor embedded in a low-cost test card, we are building the lab test of the future.

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Our Technology

An outstanding characteristic of silicon micromachining is the precise control of features at the sub-micron level. We take advantage of this property to create disposable test cards that have the quality and accuracy of lab-based tests.

Cameras and chip processors built in our smartphones currently exist of billions of transistors. We apply the power of massive parallelization and miniaturization to microfluidics: many fluidic handling steps occur in parallel at a very small scale resulting in very fast turnaround times.

A key strength of semiconductor technologies is the diversity of nanofluidic processors that can be produced on a single manufacturing platform. This level of mass customization is still unprecedented in high-volume manufacturing industries. We have designed various nanofluidic processors that fit on the same platform for applications in cytology, molecular diagnostics, clinical chemistry and immunoassays, or a combination of these.

Our Products

We are developing three nanoFluidic Processors to measure and quantify cells, nucleic acids, proteins and small molecules

They form the basis for a variety of test cards, addressing specific medical conditions or use cases, such as early screening and treatment of infectious diseases (eg. HPV, GBS, and HIV/HCV/HBV), rapid diagnosis of acute diseases (eg. viral versus bacterial infection, meningitis, and upper and lower respiratory tract infection), and (home) monitoring of patients (eg. HIV treatment efficacy, organ transplant CMV infection, and chemotherapy monitoring).

products

The Concept

Test Card

Single use
Contains Si chip
Analyzes a blood drop
sample

Reader

Multiple use
Reads the test card
Connects via USB cable

Personal Device

User interface
Desktop/laptop
Tablet/mobile phone

Cloud

Authentication
Processing & computation
Archiving
HIS connectivity

Less than 10 minutes to results

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Globally Shifting Healthcare

Our Team

Management

Nicolas Vergauwe

CEO

Christophe Van Vaeck

CFO

Oliver Davies

VP Product Development

Ben Chambers

Director Quality & Regulatory Affairs

Leander Van Neste

VP Scientific & Clinical Affairs

Board of directors

Rudi Pauwels

Chairman and serial entrepreneur

Luc Van den hove

CEO, imec

Marc Coucke

Serial entrepreneur

Michel Akkermans

Serial entrepreneur

Roald Borré

Head of Equity Investments, PMV

Ralph H. Hruban

Director of the Pathology dept., Johns Hopkins University

Pieter Bourgeois

Investment Manager, Alychlo

David Dessers

Managing Partner, Cresco Secretary to the board

Career Opportunities

We are currently looking for new team members – If you are a passionate worker and think you have what it takes, send your resume and details to jobs@midiagnostics.com

System Engineer System Engineer Leuven, Belgium About miDiagnostics miDiagnostics is developing a new generation of disposable tests that require only drops of blood and allow detection of cells, proteins, nucleic acids, and/or small molecules. Its core technology is a novel silicon-based nanofluidic processor that automatically processes the blood sample without the need of pumps or valves. There is no need for complex and costly instrumentation enabling medical decisions to be taken at the point of need or remote areas with a high level of comfort to both patients and caregivers. The Job With miDiagnostics in the feasibility phase of its product development, the company seeks to recruit a System Engineer to lead the development of the instrument. As part of the product development team, you will closely work with suppliers and lead the design, development, verification, validation and transfer to manufacturing of the company’s advanced low-cost instrumentation system. Your activities will be based in Leuven. Responsibilities: Leading all activities relating to instrumentation design and development for both experimental and product development Working closely with all other R&D departments to ensure interfaces with other sub-systems (software, disposable cartridge) are identified and considered in the design Leading all relevant electronic and mechanical engineering activities Supplier management of suppliers developing electronic and mechanical components of the system Refining and implementing detailed product specifications for the instruments under development Managing instruments development timelines and budgets Identifying and mitigating technical and logistical risks Developing and maintaining relevant design control documentation Identifying, evaluating and selecting manufacturing partner(s) for series production Profile and competences Master’s degree in electronic/electromechanical/mechanical engineering, with 5-10 years work experience Strong supplier management skills Experience with requirements writing and risk management Experience in reviewing contract manufacturer’s mechanical/optical/software specifications, test plan, verification documentation. Strong leadership and communication skills Detail-oriented, result-focused and quality driven Strong analytical and planning skills An understanding of relevant regulatory requirements within the IVD/medical industry is a plus Fluent in English The offer Full-time job at a fast-growing and ambitious start-up in the biotech industry Market competitive salary and benefits package miDiagnostics is an international-oriented company with close connections to two world class research institutions (imec and Johns Hopkins University) You will be part of an international and multidisciplinary team You can further grow in a new and exciting cutting-edge field in point-of-care diagnostics Interested? Please apply by e-mail to jobs@midiagnostics.com with reference to this opportunity. Apply now	Apply now
Quality Engineer Quality Engineer Leuven, Belgium About miDiagnostics miDiagnostics is a unique tech start-up founded by imec, the world largest R&D center in micro-and nanoelectronics, and The Johns Hopkins University. We are developing a new generation of diagnostic platform for near-patient testing based on a silicon chip and which requires only drops of blood for the detection of cells, proteins, nucleic acids, and/or small molecules. Aiming to provide the test results within the time span of a doctor’s visit, we want to bring precision diagnostics to patients and caregivers. The Job The Quality Engineer drives the quality activities within the development team. She/He will need to make sure that all the relevant design control activities are carried out to a high standard, in compliance with ISO 13485 and 21 CFR 820, and make sure that all the development team actively engage in the Design Control process. Responsibilities To work with the development teams to develop and execute plans (quality plan, risk management plan) and requirements (safety, functionality, regulatory, usability) to ensure provisions for quality are addressed and resolved prior to release To coordinate with the development of essential design control deliverables including, but not limited to product specifications, design verification, design validation, design reviews and design transfer To work closely with the development teams to develop the appropriate verification test plans and validations studies, and qualifications (subcontractors, system and subsystem) To review design inputs (specifications) and design outputs (reports, prints, etc.) to assure that appropriate design requirements are specified and to evaluate/confirm quality requirements prior to successful design transfer To participate in the change control process to review and approve engineering change requests To provide process validation support by applying manufacturing quality tools including, but not limited to: FMEA, IQ, OQ, PQ, control plans, process verification/validation plans, Cpk, Cp, SPC, DOE, process and DMAIC Profile and competences Bachelor’s Degree in engineering, Electrical, Mechanical, Industrial, Biotechnology, Engineering Technology or equivalent technical Degree; or equivalent combination of education and experience Prior Quality Engineer experience in the IVD industry or the medical device industry Knowledge of Quality System standards/regulations (ISO 13485, 21 CFR 820) Ability to read, analyze, and interpret technical procedures and governmental regulations Ability to write technical reports, business correspondence, technical procedures, as well as, administrative procedures Ability to present proposals, data, and issues to miDiagnostics personnel at all levels Ability to independently determine and develop an approach to a wide range of issues and problems. Solutions must be thorough, practical, and consistent with organization objectives Ability to represent the department in frequent cross-functional interactions and possible customer, subcontractor, or vendor contacts Ability to determine and develop technical solutions to a wide range of difficult problems The offer Full-time job at a fast-growing and ambitious start-up in the biotech industry Market competitive salary and benefits package miDiagnostics is an international-oriented company with close connections to two world class research institutions (imec and Johns Hopkins University) You will be part of an international and multidisciplinary team You can further grow in a new and exciting cutting-edge field in point-of-care diagnostics Interested? Please apply by e-mail to jobs@midiagnostics.com with reference to this opportunity. Apply now	Apply now
Software Engineer Software Engineer Leuven, Belgium About miDiagnostics miDiagnostics is developing a new generation of disposable tests that require only drops of blood and allow detection of cells, proteins, nucleic acids, and/or small molecules. Its core technology is a novel silicon-based nanofluidic processor that automatically processes the blood sample without the need of pumps or valves. There is no need for complex and costly instrumentation enabling medical decisions to be taken at the point of need or remote areas with a high level of comfort to both patients and caregivers. The Job We are looking for a senior software developer/engineer with strong background in developing products and services for imaging-based applications. As a developer you will be responsible for the implementation, testing and documentation of our key imaging-based algorithms. Your main assignment will be to productize and extend the prototype research algorithms that can eventually run on various platforms like laptop, mobile devices and in the cloud. You will be part of a multi-disciplinary team consisting of engineers (electronics, electrical, optics, bio), bio-physicists, fluidic designers, interface developers and other imaging specialists. Responsibilities Implementation, testing and documentation of imaging-based algorithms (Co-)Defining the architecture for the software (Co-)Defining the technology stack Optimize the prototype image processing & computer vision algorithms onto various platforms (laptop/mobile/cloud) Interface with various external partners for algorithmic API interfaces for GUI & other software elements Contribute to the roadmap of software developments Interact with research teams and product development teams Create and maintain key software specifications Create and maintain key documentation relevant for regulatory approvals Profile and competences You have a Professional Master’s degree in Informatics or equivalent through experience You have at least 5 years of software product development experience, preferentially in a diagnostic or medical domain You have knowledge of or exposure to standard image processing & computer vision algorithms and techniques, preferably in an industrialized context You are familiar with optimizing image processing & computer vision algorithms for CPU or GPU platforms You are familiar with standard product development languages such as (modern) C++, and can learn a new programming language rapidly You are familiar with defining APIs and developing software architectures Experience with Python & MATLAB is a plus Experience with standard imaging processing libraries (e.g. OpenCV) is a plus Experience with cloud processing, big data or web technologies is a plus Experience/knowledge about regulations for biomedical software is a plus (GDPR, HIPAA) Experience with point-of-care medical devices is a plus You are structured, precise and care about details. You attach importance to software robustness, appearance and user friendliness. You recognize a code smell when you see one. You are very customer-oriented. You are a self-motivated team player. You are fluent in English and have good communication skills The offer Full-time job at a fast-growing and ambitious start-up in the biotech industry Market competitive salary and benefits package miDiagnostics is an international-oriented company with close connections to two world class research institutions (imec and Johns Hopkins University) You will be part of an international and multidisciplinary team You can further grow in a new and exciting cutting-edge field in point-of-care diagnostics Interested? Please apply by e-mail to jobs@midiagnostics.com with reference to this opportunity. Apply now	Apply now
Silicon Process Integration Engineer Silicon Process Integration Engineer Leuven, Belgium About miDiagnostics miDiagnostics is a start-up that develops a radically new diagnostic platform for near-patient testing that overcomes the limitations of current decentralized rapid testing: combining affordability with the simultaneous measurement of a large number of biomarkers to provide an actionable answer to the treating physician. At the heart of the miDiagnostics platform is a nanoFluidic Processor (nFP), a silicon chip that controls all required liquid manipulations fully passively, removing the need for complex and costly instrumentation. Our nFP leverages existing large-scale semiconductor manufacturing processes and tools. In its final form factor, the nanoFluidic Processor is embedded into a plastic test card with on-board reagents, the size of a credit card, and is being read out by a compact reader. The Job We are looking for an experienced engineer with expertise in silicon process integration, who is familiar with process and module step development, and capable of managing device integration projects involving close collaboration with designers and characterization engineers. For our diagnostics products we seek candidates capable of building and analyzing complex integration flows involving either CMOS or MEMS process steps. Good communication skills and experience in collaborating within a multidisciplinary team including design, system and application engineers and biologists are essential. Responsibilities Manage and steer the research and development activities of the nanoFluidic Processor Collaborate within the larger miDiagnostics product development team and cascade system level requirements into silicon device specifications Manage and work collaboratively with R&D and foundry partners to develop device integration flow(s) Analyse in-line and end-of-line metrology and characterization data to drive decision making and prioritization Identify process integration technical risks and proactively seek mitigation strategies while keeping in mind the connection to other system components and overall project goals Manage timeline and resources according to agreed development plan Clearly communicate towards product development team, senior management, and technical partners regarding technical status, issues, and planning Adapt quickly to new technical challenges or business requirements Work efficiently in a multidisciplinary environment with engineers and scientists focusing on design, systems and applications aspects Profile and competences You have a Master’s or preferably a PhD degree in Electrical Engineering, Physics, Mechanical Engineering or a related technical field You have at least 10 years of working experience in semiconductor process integration in an industrial context You have experience in working in a product development environment involving both research and development activities. Experience with life sciences products is a plus. You have experience in 200mm process technology, with good knowledge in the deposition, etch, cmp, and lithography areas You have experience in managing technical teams, external contractors, and/or supply chain partners You show a hands-on approach with excellent engineering skills and a personal drive to achieve project goals You are able to take initiative and work independently, while being part of a team You have excellent communication skills The offer Full-time job at a fast-growing and ambitious start-up in the biotech industry Market competitive salary and benefits package miDiagnostics is an international-oriented company with close connections to two world class research institutions (imec and Johns Hopkins University) You will be part of an international and multidisciplinary team You can further grow in a new and exciting cutting-edge field in point-of-care diagnostics Interested? Please apply by e-mail to jobs@midiagnostics.com with reference to this opportunity. Apply now	Apply now
Process Development Engineer Process Development Engineer Leuven, Belgium About miDiagnostics miDiagnostics is developing a new generation of disposable tests that require only drops of blood and allow detection of cells, proteins, nucleic acids, and/or small molecules. Its core technology is a novel silicon-based nanofluidic processor that automatically processes the blood sample without the need of pumps or valves. There is no need for complex and costly instrumentation enabling medical decisions to be taken at the point of need or remote areas with a high level of comfort to both patients and caregivers. The Job miDiagnostics is looking for an experienced, talented and versatile process development engineer responsible for the development and optimization of silicon-chip back-end processes in the production flow of a medical diagnostics device prototype. The processes will be focused around surface modifications of Si: (plasma) cleaning and thin organic film depositions (CVD). You will be responsible to develop and optimize the processes. Responsibilities Develop, qualify and implement surface modifying processes starting from feasibility through optimization and validation to transfer to production Develop and execute design and process validation activities including Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ) protocols, testing and reports Identify and troubleshoot process-related issues Profile and competences Master degree in engineering, with minimum 5 years of relevant industrial experience in process engineering, preferably in the semiconductor, medical devices or IVD industry Hands on attitude and drive to develop robust and manufacturing compatible processes Have passion and enthusiasm for developing new products & processes Deep knowledge of surface chemistry and surface characterisation techniques Experience with silicon-based surface cleaning and coating is a plus Experience with chemical vapor deposition (CVD) process is a plus Experience in methodology for DOE is highly desirable Knowledge of Process Excellence (Six Sigma black belt certified is a plus) is preferred Strong analytical, problem-solving and decision-making skills Consistent delivery of timely, accurate and thorough work products Strong time management and organizational skills in a dynamic, continually changing environment Technical leader who can take initiative and work independently Excellent communication skills at all levels in the company Team player Fluent in English The offer Full-time job at a fast-growing and ambitious start-up in the biotech industry Market competitive salary and benefits package miDiagnostics is an international-oriented company with close connections to two world class research institutions (imec and Johns Hopkins University) You will be part of an international and multidisciplinary team You can further grow in a new and exciting cutting-edge field in point-of-care diagnostics Interested? Please apply by e-mail to jobs@midiagnostics.com with reference to this opportunity. Apply now	Apply now
Research Scientist Research Scientist Leuven, Belgium About miDiagnostics miDiagnostics is developing a new generation of disposable tests that require only drops of blood and allow detection of cells, proteins, nucleic acids, and/or small molecules. Its core technology is a novel silicon-based nanofluidic processor that automatically processes the blood sample without the need of pumps or valves. There is no need for complex and costly instrumentation enabling medical decisions to be taken at the point of need or remote areas with a high level of comfort to both patients and caregivers. The Job You will become part of a team of scientists and engineers that is developing a new device for molecular diagnostic testing. In your role of Molecular Biologist, you will develop and optimize new assay principles for nucleic acid purification, extraction, amplification and detection on a silicon chip. In particular, you will: Develop new methods for nucleic acid extraction within a silicon chip Develop new methods for nucleic acid amplification and detection Develop new sample prep methodologies to purify nucleic acids from diverse clinical sample specimen Design and optimize assays to be run on the silicon chip Interact with silicon chip designers and process engineers to match the silicon chip to the needs of the molecular biology and vice versa Profile and competences You have a MSc or PhD degree in molecular biology, (bio)chemistry engineering or bioscience engineering Ideally, several years of experience in PCR, assay design and/or other ways of nucleic acid detection technologies Experience in de novo assay development, not based on existing kits, is a plus A keen interest in novel technologies for molecular diagnostics A thorough understanding of chemistries related to nucleic acids and solid phases is a plus Experience in microfluidics is a strong plus Hands-on and resourceful problem solver is a must Attention to detail, works in a structured and methodological way Team-player Excellent communicator Fluent in English The offer Full-time job at a fast-growing and ambitious start-up in the biotech industry Market competitive salary and benefits package miDiagnostics is an international-oriented company with close connections to two world class research institutions (imec and Johns Hopkins University) You can further grow in a new and exciting cutting-edge field in point-of-care diagnostics Interested? Please apply by e-mail to jobs@midiagnostics.com with reference to this opportunity. Apply now	Apply now
Process Development Technician Process Development Technician Leuven, Belgium About miDiagnostics miDiagnostics is developing a new generation of disposable tests that require only drops of blood and allow detection of cells, proteins, nucleic acids, and/or small molecules. Our core technology is a novel silicon-based nanofluidic processor (nFP) that automatically processes the blood sample without the need of pumps. miDiagnostics’ ambition is to remove the need for complex and costly instrumentation enabling medical decisions to be taken at the point of need or remote areas with a high level of comfort to both patients and caregivers. The Job You will be part of a dynamic, international and multidisciplinary team that develops a completely new medical diagnostic device to be used at the point of need. As “Process Development Technician” you will support processing activities related to back-end processing of the silicon-based nFP. You will generate the necessary data and knowledge to make the transition from test prototypes to market ready products. You will also provide the development teams with the necessary components to support the prototype manufacturing and testing needs. Responsibilities Test and evaluate chemical vapour deposition, plasma cleaning and spotting processes for the silicon-based nFP, in close collaboration with our process development engineer Develop and execute test plans, protocols and Standard Operation Procedures (SOPs) Analyse and interpret experimental data and present the results to project teams Prepare and write technical reports and other relevant documentation Execute key manufacturing process steps to deliver functional nFP to the development teams Profile and competences You have a BSc or equivalent by experience in a life science related field: (bio)chemistry, (bio)chemistry engineering technology or lab technician Preferably have three years of industrial experience Knowledge of surface chemistry and/or experience in coatings is an advantage Experience in highly regulated industry, such as pharmaceuticals or medical devices (ISO 13485) is considered a plus Experience in methodology for DOE is a plus Hands-on and resourceful problem solver Attention to detail, works in a structured and methodological way is a must Team-player Excellent communication and reporting skills Fluent in English The offer Full-time job at a fast-growing and ambitious start-up in the biotech industry Market competitive salary and benefits package You will be part of an international and multidisciplinary team You can further grow in a new and exciting cutting-edge field in point-of-care diagnostics Interested? Please apply by e-mail to jobs@midiagnostics.com with reference to this opportunity. Apply now	Apply now