Head of Instrumentation

Leuven - Engineers
|
More than two weeks ago

miDiagnostics is looking for a Head of Instrumentation to lead the design, development, verification, validation and transfer to manufacturing of the company’s advanced low-cost instrumentation system.

Head of Instrumentation

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 Head of Instrumentation. Reporting to the Vice President Product Development, the Head of Instrumentation will 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 purposes
  • 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
  • Troubleshooting of technical issues with existing instrumentation and defining and executing improvement plans
  • 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
  • Working with the VP Quality and Regulatory to create appropriate validation and verification activities
  • Some travel will be required, especially initially, to align the different international parties

Profile and competences

  • Master's degree in electronic/electromechanical/mechanical engineering
  • Experience in working in a fluid, fast-paced, hands-on setting with a high degree of complexity
  • Strong supplier management skills
  • Strong experience in transferring prototype design to high-volume contract manufacturing organization
  • Experience with requirements writing (including usability requirements is a plus)
  • Experience in reviewing contract manufacturer’s mechanical/optical/software specifications, test plan, verification documentation. Experience in change management and risk analysis
  • Strong leadership and communication skills
  • Detail-oriented, result-focused and quality driven
  • Strong analytical and planning skills
  • International experience coordinating teams across multiple sites and geographies is a plus
  • An excellent understanding of relevant regulatory requirements within the IVD industry
  • 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.

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