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

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

• Successfully completed bachelor’s or master’s degree in technical or engineering field
• Experience in the field of Regulatory or Quality Assurance Medical Devices/Medical Products/ Digital Products/ Software
• Knowledge in the field of development and/or manufacture and control of Medical Devices and Medical Products
• Advanced knowledge of applicable quality management and of software lifecycle standards (e.g. ISO13485, IEC62304, EU Guidelines for GMP, IFDA 21 CDR §820.250, etc.)
• Advanced knowledge of medical device regulations (MDR 2017/745, etc.)
• Knowledge of internal and external processes and structures and of the Quality Management System requirements
• Experience with QTRAK, PDM systems as PTC Windchill, FMEA tools would be a plus
• 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