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.
Your tasks
- 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
Your profile
- 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