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Fresenius Medical Care North America Design Quality Engineer (Digital Products) (m/f/d) in Schweinfurt, Germany

In your role as Design Quality Engineer (Digital Products) (m/f/d) you will be working to ensure the quality and reliability of digital products, while minimizing risks to patients, with a specific focus on software for medical devices and digital products. Your responsibility will also include maintaining excellence in software quality by employing modern quality assurance methodologies.

Your tasks

  • Provide guidance and support on software quality assurance matters, including but not limited to software testing, integration testing strategies and release readiness

  • Collaborate with engineering teams from the early stages of development to provide quality assurance input and support

  • Provide guidance and support on software development process matters

  • Evaluate modern software quality methods, track progress, and introduce improvement plans

  • Integrate software quality assurance activities into agile development workflows

  • Define and monitor software quality metrics, communicating risks to stakeholders

  • Create project-specific quality strategies and operationalize them with tailored measures

  • Improve existing software product lifecycle processes and support compliance to current regulatory requirements for medical software (e.g., IEC 62304, IEC 82304, IEC 81001-5-1, IEC 61508-1, ISO 13485, ISO 14971)

  • Assist in management of defects, bug fixes, and anomalies

  • Identify opportunities for improving software quality processes and methodologies through lessons learned and feedback

Your profile

  • Bachelor’s or master’s degree in computer science, engineering, or related field

  • Experience in quality assurance or software development for web and/or cloud systems

  • Experience in medical product development or other regulated industry

  • Strong understanding of software development processes and methodologies

  • Strong understanding of cloud and web technologies

  • Preferably, experience with IoT system development

  • Programming experience

  • Good and professional relationship and communication with colleagues and internal and external customers

  • High engagement in achieving the targets and objectives of the position, with a proactive and solution-oriented approach to problems and priority setting

  • Good handling of moderation and presentation techniques

  • Fluent in German and English, both written and spoken

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