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Head of System Verification

vor 1 Monat

Frankfurt Am Main, Deutschland Fresenius Medical Care Vollzeit

In your role as Head of System Verification (M/F/d) you will be responsible for verification with the goal of achieving CE and CFDA approval of systems. You will provide verification capacity for various project groups and be responsible for schedule, capacity, and budget planning in coordination with the project managers.

**Your assignments**:

- Professional and disciplinary leadership of a verification team
- Expand and refine future verification strategies, in coordination with other verification teams in the company
- Further development of the test methodology with a focus on automated tests
- Responsibility for planning, execution and evaluation of system and software verifications
- Support of the project team in reviewing performance data, functionality, and electrical, design, and functional safety
- Further development of internal guidelines and quality standards for the development process
- Coordinate and perform activities to achieve CE, FDA(USA)/ 510(k) and NMPA approval (conformity assessment procedures) for medical devices
- Further development of methods for managing processes in the context of verification
- Coordination and implementation of system and software verifications with external service providers
- Leading, coaching and motivating group staff to meet group and project goals
- Identification of problems in motivation and cooperation and initiation of appropriate countermeasures
- Coordination of further technical development with other verification groups in the company
- Further development of the organization and methods

**Your profile**:

- Completed technical studies (diploma, master's degree) in electrical
- and information technology, medical technology or similar with professional experience in software testing environment as well as experience in the employee management
- Several years of professional experience in medical technology, with team leadership or technical supervisor function
- Many years of professional experience in the software testing environment
- Experience in the area of test automation (processes and methods)
- Good software knowledge in C, C++ and Python
- Experience in verification of complex systems including knowledge of appropriate methods
- Knowledge about the approval of medical devices and legal requirements (e.g. MDR, MPG, IEC 62304 and other relevant standards)
- Familiar with risk management
- Knowledge of CMMI or Medical Spice desirable
- IT user skills in MS Office and MS Project
- Good English skills (written and spoken)
- Willingness to travel within Germany and international

Nice to have
- Good knowledge of national and international standards regarding constructional, electrical and functional safety of dialysis machines
- Knowledge of Fresenius Quality Processes

**Our offer to you**:
There is a lot for you to discover at Fresenius, because we have a lot to offer. No matter in which field you are an expert (M/F/d) and how much experience you bring with you - for your professional future with meaning:

- The opportunity to work on a mobile basis, individually in consultation with your manager
- Whether in front of or behind the scenes - you will help to make better and better medicine available to more and more people around the world
- Individual opportunities for self-determined career planning and professional development
- A corporate culture in which there is enough room for innovative thinking - to find the best, not the fastest, solution together
- A large number of committed people with a wide range of skills, talents and experience
- The benefits of a successful global corporation with the collegial culture of a medium-sized company

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