Beschreibung

In this role, you will be at the forefront of product development, defining system designs, managing technical implementations, and ensuring compliance with industry standards. Your day-to-day responsibilities will involve collaborating with various stakeholders and supporting the transition of products from design to production.

Anforderungen

• •Dipl.-Ing./Master in Electrical Engineering, Medical Engineering, Mechanical Engineering, Materials Engineering, Biology, or equivalent
• •4+ years of systems engineering experience
• •Very good knowledge of system development and/or software design
• •Very good knowledge of embedded systems, software, mechanics, and hardware
• •Expertise in defining requirements or requirements management systems
• •Experience in verification procedures
• •Experience in Design to Cost
• •Experience in the transfer of sterile tubing sets to the medical device industry
• •Experience in transferring medical devices to production
• •Knowledge of verification procedures
• •Knowledge of relevant norms, standards, and approval process (FDA; CE)
• •Fluent German
• •Good knowledge of English (at least B2)
• •Experience in use of requirement management tools (like Polarion, Doors)
• •SAP knowledge desirable
• •Quality-conscious, trustworthy, and reliable
• •Willingness to travel to all locations and business contacts
• •Team player
• •Very good communication skills
• •Structured, systematic, and solution-oriented way of working

Aufgaben

• •Define and document system design based on specified architecture
• •Analyze external and internal stakeholder requirements
• •Pre-select and allocate customer requirements to existing platform solutions
• •Coordinate with stakeholders as necessary
• •Define features for integration and create feature requests if needed
• •Implement new product features as reusable components of the platform
• •Create product-specific system specifications
• •Coordinate technical solutions across departments
• •Manage technical project components with the project manager
• •Support associated work packages with content-related guidance
• •Create and maintain technical documentation with the project manager
• •Manage product-specific risk in collaboration with the risk manager
• •Develop and implement product-specific verification plans
• •Oversee technical management of device constructions (Alpha, Beta, Vali)
• •Review and approve assembly instructions
• •Transfer products to production
• •Conduct standard tests of the device
• •Support production processes up to pilot series (NPI)
• •Provide technical support for production (PE)
• •Integrate domain-specific development results
• •Control material and parts list creation and management
• •Serve as the technical contact for customers, suppliers, and partners
• •Organize department-specific training
• •Assess the impact of changes in standards on the field
• •Collaborate intensively within the development department and company-wide
• •Participate actively in developing and applying company standards
• •Initiate and engage in synchronization processes and process improvements
• •Contribute to the innovation process
• •Ensure compliance with quality, safety, and environmental regulations

Tools & Technologien