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Medical Software Validation Specialist (m/w/diverse)

If you are ambitious and change makes you thrive, then immerge into the development process of a medical software with all it´s technical, regulatory, customer-focused and economic aspects. 


NEO New Oncology GmbH – a Siemens Healthineers Company – is a dynamically growing diagnostics company offering products for molecular diagnostics to identify optimal treatment options for cancer patients. Our technology platform “NEO” is based on next generation sequencing and proprietary computer algorithms. NEO reliably identifies therapy-relevant genetic alterations from standard clinical material such as FFPE specimens and liquid biopsies with short turnaround times and highest accuracy.

 

To expand our current capabilities, we are seeking a highly motivated

Medical Software Validation Specialist (m/w/diverse)

 

Your responsibilities

  • In this role you are responsible for active planning and execution of validation and qualification related tasks, regulated by the development process, regulations and norms
  • You support  and represent the Team Lead, you also support and represent the software development management
  • You are responsible for cost, effort and time estimation for development projects in collaboration with the Team Lead 
  • You collaborate with software architects, developers and validation support and with other teams of NEO´s R&D department and IT department
  • You perform gap analyses
  • You are responsible for planning, execution and documentation of project related test plans and specifications as well as for definition and creation of documents/templates relevant for software development
  • You support ISO 13485 certification tasks
  • You support Siemens integration tasks. In addition you support and secure the implementation of Siemens´ Privacy by Design standards and GDPR requirements

 

This position may suit you best, if you have a high affinity with IT and QM related topics, are used to work cross-functionally, you make things happen with the right sense of urgency and impact.

  • You hold a university degree in business informatics, computer science or in other related scientific discipline
  • You bring several years of relevant work experience in the software development and/or regulatory field
  • You have a strong organizational awareness, you are a true team player with excellent communication skills, business focused, pragmatic and a well-structured way of thinking and working
  • You bring problem-solving ability and attitude combined with a self-organized and independent working attitude
  • You have a solid understanding of quality management/assurance
  • You are fluent in German and English, written and verbal

 

If you want to join us in transforming the way healthcare is delivered, get in touch with us.

Type of Position: Permanent full-time (40 h/week)

Location: Cologne, Germany

How to apply: Please submit your application via our global Siemens Careers website. Apply here (Job-ID: 69976, Köln).

Kontakt

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Büro und Administration:
+49 221 888 23 80
 

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Adresse

NEO New Oncology GmbH
Gottfried-Hagen-Str. 20
51105 Köln

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