Design Quality Engineer (Software) (m/f/d)
In your role asDesign Quality Engineer (Software) (m/f/d) you will beresponsible 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
Career with a purpose
Inclusion and diversity
Stability
Learning and development
Local benefits
Work-life balance
At a glance
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We care about sharing information and experiences as this helps us learn from our mistakes and each other. We tackle challenges together by reaching out to colleagues both near and far. We communicate openly.
We challenge the status quo and show interest in what happens around us. We ask questions to clearly understand what needs to be done and take ownership of the results.
We live up to our own expectations, show respect and lead by example. We act with integrity and in line with our standards every day.
We make things better today than they were yesterday. We pitch ideas on how to improve and innovate.
What we stand for
Empowering people. Advancing care. Inspiring with our purpose and values.
Everything we do here is about making people’s lives better, simpler and longer. Our teams work cross-functionally to reproduce the complex function of kidneys with treatments that meet high quality standards, improve clinical outcomes, and are sustainable and compliant. Internally, we promote diversity and inclusion as key elements of a positive, supportive work environment. Our values support our mission to develop high quality products and services, to have a positive impact on the health and wellbeing of patients, and to lead Fresenius Medical Care towards a successful, sustainable future.