Design Quality Engineer (Software)

at  Fresenius Medical Care

In your role as Design Quality Engineer (Software) (m/f/d) you will be responsible to support engineering teams in developing robust, reliable, and manufacturable designs, providing guidance and design assurance frameworks to ensure high product quality.

• Collaborate with engineering teams from the early stages of development to provide quality assurance input and support
• Conduct Software FMEA to identify and mitigate potential design failures early in the development process
• Offer ongoing support and training to engineering teams on best practices
• Collaborate with cross-functional teams to integrate quality considerations throughout the entire project lifecycle
• Assist in defining and documenting user needs, design inputs, and design specifications
• Develop, implement, and maintain design quality frameworks and guidelines to ensure consistent and high-quality design practices (e.g. Design for Manufacturing, Design for Reliability, DFSS)
• Collaborate with manufacturing quality teams to ensure proper transition from design to production
• Collaborate with supplier engineering teams to ensure that component and material suppliers meet design specifications and quality standards
• Provide guidance including but not limited to software testing, integration testing strategies and release readiness
• Provide guidance and support on software development process matters
• Perform Software Quality Assurance activities as defined, ensuring compliance with standards
• Define and monitor software quality metrics, communicating risks to stakeholders
• Support for improvement of existing product life cycle processes and support compliance to current regulatory requirements for medical software