Beschreibung

In this role, you will be at the forefront of developing medical devices, focusing on system design, feature implementation, and cross-department coordination. Your day-to-day responsibilities will involve collaborating with stakeholders, managing technical documentation, and ensuring compliance with industry standards.

Anforderungen

• •Dipl.-Ing./Master in Electrical Engineering, Medical Engineering, Mechanical Engineering, Materials Engineering, Biology, or equivalent
• •5+ years of relevant work experience
• •Proven track record in development of medical devices (Class II)
• •Very good knowledge of system development and/or software design
• •Very good knowledge of embedded systems, software, mechanics, and hardware
• •Very good knowledge of mechanics, sterility, and biocompatibility
• •Very good experience in design to cost
• •Very good knowledge of manufacturing processes of sterile tubing sets
• •Expertise in defining requirements or requirements management systems
• •Experience in verification procedures
• •Experience in Design to Cost
• •Experience in transfer of sterile tubing sets to medical device industry
• •Experience in transferring medical devices to production
• •Knowledge of verification procedures
• •Knowledge of relevant norms, standards, and approval process (FDA; CE)
• •Good knowledge of English (GER-B2)
• •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 needed
• •Define features for integration and create feature requests if necessary
• •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 and hose set constructions
• •Facilitate design transfer of products to production
• •Review and approve assembly instructions
• •Conduct standard tests for the device and hose set
• •Support production processes up to pilot series
• •Provide technical support for production
• •Control creation and management of material and parts lists
• •Serve as technical contact for customers, suppliers, and internal departments
• •Organize department-specific training sessions
• •Assess applicants and participate in interviews
• •Supervise students
• •Evaluate the impact of changes in standards
• •Mentor team members
• •Collaborate intensively within the development department
• •Participate in the development of company standards
• •Initiate and engage in synchronization processes and process improvements
• •Contribute to the innovation process
• •Ensure compliance with quality, occupational safety, and environmental regulations

Tools & Technologien