Development Engineer System Verification in Mannheim bei Roche

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As a Development Engineer (m/f/d) for System Verification, you are responsible for system verification in highly complex cross-functional system development projects at the Roche site in Mannheim.

• You independently plan System Performance Verification according to target specifications in coordination with the respective technical projects, taking into account specifications, requirements, and risks.
• You represent quality issues within the project for verification documents and provide advice for decision-making, considering CLSI, SOPs, and regulatory requirements through subject matter experts.
• You support specifications/requirements regarding regulatory requirements and previous project experiences.
• You independently lead technical projects within a technology or product development process.
• You assess system performance in collaboration and close coordination with Regulatory Affairs Managers, Biostatistics and Mathematics, Global Clinical Program Leads, Assay Development, and System Engineers.
• You regularly coordinate with hardware verification and software verification to ensure a smooth process and create and review project-related documentation.

• Completed technical or scientific studies (Master FH) in the fields of Chemistry, Biology, Medical Technology, or a comparable field
• +5 years of relevant professional experience in the development of diagnostic measurement systems
• Good knowledge in the field of point-of-care measurement systems, particularly technical evaluations and measurement methods, and experience in creating regulatory-compliant documents such as test plans and result reports
• Experience in the application of statistical methods as well as in project management and leadership in a matrix organization
• Analytical thinking and problem-solving skills, good communication and coordination abilities
• Experience in agile development projects and the ability to work in a challenging, dynamic, and constantly changing environment

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At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

With round about 8,000 employees Mannheim is the third largest Roche site in the world. It headquarters the Diabetes Care business unit and the sales organization of diagnostics products and is the hub of the worldwide diagnostics business. From your beginning with Roche, our motivated team will welcome and support you. Numerous opportunities for personal development, flexible work hours, attractive compensation packages and special family assistance programs are available.