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Summary
Professional management of the technical project components and content-
related support of the associated work packages (target definition, definition
of done) in a change project, together with the project manager and the
PE-team.
Primary Responsibilities
1. Technical evaluation of product changes
2. Development of test and verification plans for product changes and validations based on the technical evaluation.
General Tasks
3. Evaluation and documentation of product changes based on the system architecture, considering existing specifications, risk management, regulatory and normative provisions.
4. Review of risk management in the context of product changes
5. Monitoring the technical progress of product change projects
6. Responsible for repeating standard tests of the device as part of product changes.
7. Creation and maintenance of technical documentation for own area of responsibility.
8. Technical contact for customers and external development partners.
9. Control of material and parts list creation/management in the context of product changes.
Required Experience, Education, Skills, Training and Competencies
10. Several years of development experience in the field of plastics development or plastics processing
11. Independent and interdisciplinary solution finding for projects.
12. Knowledge of system development and/or software design
13. Development experience in a medically regulated environment; knowledge of the relevant regulations
14. In-depth knowledge of plastic materials in medical technology
15. Quality-conscious, trustworthy and reliable
16. Able to work in a team
17. Communicative skills
18. Structured and systematic way of working
19. SAP knowledge
20. Basic knowledge of English (GER-B2)*
Travel Requirements
21. Willingness to travel to all locations and business contacts
Physical Requirements
22. none
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