Tasks:

• Develop and deploy application and security components for new lab projects using shared web hosting, virtualized cloud computing providers, and collocated servers
• Work with internal research team to setup and maintain Dev, QA and Production environments
• Create and maintain ad-hoc application environments for the team
• Seek out opportunities to develop and improve existing automation processes
• Monitor the health of the production and QA environments
• Troubleshoot and debug build issues, with a willingness to resolve problems
• Collect and report on operational metrics for SLA reporting and capacity planning
• Collaborate with other groups by seeking, using and giving feedback

Requirements/Qualifications:

• Knowledge of virtualization environments (e.g. VMWare, OpenStack, KVM)
• Knowledge of distributed version control systems (e.g. Git/Stash)
• Experience with automated build and deployment tools (Jenkins, Chef, etc.)
• Experience working on open source platforms (Apache, Tomcat, nginx, Node.js, etc.)
• Hosted and cloud-based service experience (EC2/AWS and/or private cloud)
• Installing and administering MySQL or open source no-SQL databases
• Excellent writing and communication skills
• BS or higher education in Computer Science, Software Engineering or IT-oriented degree program
• 5+ years Operations experience, preferably in a DevOps or similar role
• Experience with task automation using open source, customized scripts, and/or off-theshelf tools
• Experience administering Linux systems and server infrastructure
• Experience managing automated build, continuous testing and integration systems and infrastructure supporting applications in a production environment

Tasks:

• Maintenance and continuous improvement of the QM system (document change control, handling of non-conformities, etc.)
• Maintenance of technical files.
• Ensuring product conformity to all applicable regulatory provisions before delivery to the customer.
• Advise specialist departments in daily quality-related activities including planning and execution of employee training.
• Performing assessments of documented regulatory requirements and QM system documentation.

Qualifications:

• Effective communication in international and interdisciplinary teams and active listening skills.
• Fluent in English and German.
• At least 2 years of experience in managing QM systems covering ISO 13485, ideally involving development of medical device software.
• Experience in generating and adapting SOPs and Working Instructions together with specialist departments such as Research & Development and Product Management.
• In-depth knowledge of European medical device legislation, especially Regulation 2017/745 as well as German law (MPG, MPSV, HWG).
• Knowledge of ISO 14971, EN 62304, EN 62366 and ideally EN 82304.
• Ideally experience in conducting internal audits.

We are warmly welcoming students searching for internships, bachelor or master projects. In our small company students can learn many different things and will be included into the development or productions process immediately. We ask for interest in state-of-the-art technology, computer knowledge and interest in medical device development. Contact us, if you are interested!

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