Design Quality Engineer (Software) (m/w/d)

Fresenius Medical Care North America Design Quality Engineer (Software) (m/w/d) in Schweinfurt, Germany

Ihre Aufgaben

In your role as Design Quality Engineer (Software) (m/f/d) you will be working as a part of product development teams to ensure the quality and reliability of 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

• Collaborating 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 in 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 life cycle 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

Ihr Profil

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

• Experience in software quality assurance or software development

• Experience in medical software development or other regulated industry

• Strong understanding of software development processes and methodologies

• Knowledge of modern software quality techniques

• Programming experience

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

• High engagement on achieving the targets and on the objectives of the position, proactive and solution-oriented approach towards problems and priority setting

• Good handling of moderation- and presentation techniques

• Fluent in German and English, in written and spoken