Medical Devices Systems Engineer
vor 1 Monat
Role Summary
This position is responsible for the technical implementation of products based on defined architecture and master specifications in accordance with company-wide design control guidelines. The development focus of this role is on medical accessories, e.g., tube sets for insufflators and pumps.
Main Responsibilities
- Definition and documentation of the system design on the basis of the given architecture and platform development, taking into account regulatory and normative provisions.
- Analysis of external/internal stakeholder requirements.
- Pre-selection and assignment of customer requirements to existing solutions of the platform, coordination with stakeholders if necessary.
- Determination of the features to be integrated, creation of a feature request if necessary.
- Responsibility for the technical implementation of new product features, preferably as a reusable component of the platform.
- Creation of product-specific system specifications.
- Coordination of technical solutions between the individual departments
- Technical management of the technical project components and content support of the associated work packages (target definition, DoD) together with the project manager and the departments.
- Preparation and maintenance of technical documentation together with the project manager.
- Responsible for product-specific risk management in cooperation with the risk manager.
- Responsible for the product-specific verification plans and their successful implementation.
- Technical management of the equipment and hose set constructions (Alpha, Beta, Vali).
- Transfer (design transfer) of the products to production.
- Responsible for the review and approval of assembly instructions.
- Responsible for the standard tests of the device and tube sets.
- Support of manufacturing processes up to pilot series (NPI); Technical support of production (PE).
- Control of material and BOM creation/management.
- Preparation and maintenance of technical documentation together with the project manager.
- Responsible for the technical approval of the products by the customer.
- Technical contact person for customers (e.g., project acquisition)
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