Job Information
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
Fresenius Medical Care North America
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