Development Engineer (m/f/d) System Verification

at  Roche

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The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
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.

Your key responsibilities

• 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.

Your Profile

• 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

This position is temporary for 2 years.
Your application
We make things easier for you: Please upload only your current and compelling CV and your certificate of your highest degree.
We look forward to receiving your application!

• 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