荷语区鲁汶大学

MSCA ETN ETERNITY: Towards standardized EMC assurance case patterns for the certification of medical equipment

项目介绍

The ETERNITY Beneficiaries are 3 high-technology companies in the area of medical technology: Philips Medical (NL), PLUX (PT), and Ficosa (ES). The consortium is completed by 5 universities: TU Eindhoven (NL), University of Twente (NL), KU Leuven (BE), Universitat Politècnica de Catalunya (ES), and FCT/UNL Lisboa (PT). Together, these universities have a proven track record in the management of electromagnetic interference (EMI), medical engineering, system engineering and risk management, and are the leaders in their field in Europe. The essential clinical involvement is arranged via 2 hospitals, which are Partner Organisations in ETERNITY: Hospital Utrecht (NL) and Hospital CIMA Sanitas (ES). The industrial involvement is completed by 3 Partner Organisations: Eurofins (BE), Barco (BE) and the start-up Plasmacure (NL). Each of the 14 ESRs will be trained to work in multi-disciplinary and multi-cultural teams, with a new mindset tuned towards the inclusion of the three main elements of a risk-based approach into innovative design methods (e.g., concurrent engineering and agile/scrum design methods). For this inclusion to occur, each ESR will develop through their research the missing dedicated tools and techniques, and apply them to a representative set of medical devices under development. This hands-on training is supplemented with several scientific professional courses and an immersive training where the ESRs can fine-tune their skills for the Jobs of tomorrow, while addressing the societal challenges of the ETERNITY program. This particular ESR-position will be executed with the M-Group at KU Leuven Bruges Campus.Website unit

Project

In the end, both the EMC and Medical Directives require the manufacturer to clearly document all steps taken and decisions made to guarantee and check the conformity of the product in the so-called Technical Documentation. The purpose of the Technical Documentation is to make it possible for an external independent, external assessor or for the final user to (i) reproduce the whole reasoning followed by the manufacturer, (ii) assess the conformity of the product as well as (iii) get an overview of all (design) measures that were needed to get to that conformance or any assumptions that there might concerning the use or installation of the product. Unfortunately, there is no standardized way to write down the Technical Documentation. As a result, Technical Documentation can look very different, making it quite difficult to interpret and follow them. Looking outside of the field of EMC, standardized notations to structure and present arguments are available. More specifically, different types of graphical notations have been developed for safety assurance cases for safety critical systems, such as the Goal Structuring Notation (GSN), the Claims-Arguments-Evidence (CAE) notation and very recently the Structured Assurance Case Metamodel (SACM) language. In this ESR project, the use of these graphical notations for documenting the overall EMC assessment of medical equipment is explored in depth, leading to a set of EMC assurance case patterns or templates.

Profile

Career stage: Early Stage Researcher (ESR) or 0-4 yrs (Post Graduate)
Eligibility Criteria:

  • Early-stage researchers (ESR): those who are, at the time of recruitment by the host, in the first four years (full-time equivalent) of their research careers. This is measured from the date when they obtained the degree which formally entitles them to embark on a doctorate, either in the country in which the degree was obtained or in the country in which the research training is provided, irrespective of whether or not a doctorate was envisaged.
  • Conditions of international mobility of researchers: researchers are required to undertake trans-national mobility (i.e. move from one country to another) when taking up the appointment. At the time of selection by the host organisation, researchers must not have resided or carried out their main activity (work, studies, etc.) in the country of their host organisation for more than 12 months in the 3 years immediately prior to their recruitment. Short stays, such as holidays, are not taken into account.
  • English language: Network fellows (ESRs) must demonstrate that their ability to understand and express themselves in both written and spoken English is sufficiently high for them to derive the full benefit from the network training.

Offer

The successful candidates will receive an attractive salary in accordance with the MSCA regulations for Early Stage Researchers. The exact (net) salary will be confirmed upon appointment and is dependent on local tax regulations and on the country correction factor (to allow for the difference in cost of living in different EU Member States). The salary includes a living allowance, a mobility allowance and a family allowance (if married). The guaranteed PhD funding is for 36 months (i.e. EC funding, additional funding is possible, depending on the local Supervisor, and in accordance with the regular PhD time in the country of origin). In addition to their individual scientific projects, all fellows will benefit from further continuing education, which includes internships and secondments, a variety of training modules as well as transferable skills courses and active participation in workshops and conferences.

Interested?

For more information please contact Prof. dr. ir. Davy Pissoort, tel.: +32 50 66 48 49, mail: davy.pissoort@kuleuven.be or Mr. Tim Claeys, tel.: +32 50 66 48 48, mail: tim.claeys@kuleuven.be.You can apply for this job no later than June 21, 2021 via the online application toolKU Leuven seeks to foster an environment where all talents can flourish, regardless of gender, age, cultural background, nationality or impairments. If you have any questions relating to accessibility or support, please contact us at diversiteit.HR@kuleuven.be.

录取要求

  • Early-stage researchers (ESR): those who are, at the time of recruitment by the host, in the first four years (full-time equivalent) of their research careers. This is measured from the date when they obtained the degree which formally entitles them to embark on a doctorate, either in the country in which the degree was obtained or in the country in which the research training is provided, irrespective of whether or not a doctorate was envisaged.
  • Conditions of international mobility of researchers: researchers are required to undertake trans-national mobility (i.e. move from one country to another) when taking up the appointment. At the time of selection by the host organisation, researchers must not have resided or carried out their main activity (work, studies, etc.) in the country of their host organisation for more than 12 months in the 3 years immediately prior to their recruitment. Short stays, such as holidays, are not taken into account.
  • English language: Network fellows (ESRs) must demonstrate that their ability to understand and express themselves in both written and spoken English is sufficiently high for them to derive the full benefit from the network training.

项目概览

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欧陆, 荷兰 所在地点
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截止日期 2021-06-21
荷语区鲁汶大学

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