Systems Engineer - Integration and Configuration Management

Role:

The System Engineer - Integration and Configuration Management has system engineering responsibilities for the definition, management, and maintenance of integration activities along the lifecycle of radiotherapy devices and solutions (system of systems including integrated and interoperable 3rd party products) as part of the solution engineering activities. Furthermore, the job holder is responsible for the development, management and maintenance of system configuration baselines and ensures that these configuration baselines fulfil traceability and documentation requirements as part of design control.

This role is responsible for the definition of integration and configuration management strategies along the full cycle of the V-model and coordinates the effective realization of the defined strategies across the different layers of the V-model, in line with the overall system engineering development process.

Responsibilties:

• Create an integration concept including the integration sequence and maturity planning for the specific implementation of the integration strategy - also factoring in costs, quality, and deadline requirements for a diverse range of medical devices solutions.

• Virtual and physical management of the technical content for each integration step along the different layers of the V-model

• Confirming the integration readiness, including recommendations for approvals for V&V (verification and validation)

• Create and maintain traceability reports between different configurations of the medical solutions and systems!

• Monitoring of configuration management activities and creation of related baselines in accordance with the project lifecycle

• Ensuring baselines definition and specification are compliant with the QMS for all changes.

• Maintenance and continuous improvement of existing product configuration models within the whole lifecycle of the products

• Collaboration in the standardization and modularization of the of the product DHF structure

• Assist in the preparation of documentation for internal, external, and customer configuration management audits.

• Support cross-functional initiatives to improve processes, methods, and tools with respect to configuration, document, and data management.

Required experience:

• Degree in Engineering or applicable technical/scientific discipline.

• In-depth knowledge of integration-, configuration- and change management

• Excellent stakeholder's management skills

• Demonstrated experience in working with PLM/PDM systems such as Polarion.

• Previous experience in delivering complex platforms/systems, preferably in the medical devices industry, is an advantage.

• Experience in function-oriented and system-oriented development

• Ability to apply system thinking and a modular approach to product ownership throughout the lifecycle.

• Experienced in the application of system engineering practices.

• Medical sector specific knowledge is desirable, including ISO 13485, IEC 60601.

• Demonstrated aptitude for strategic thinking and problem solving with the ability to implement through others.

• Excellent communication skills (verbal and written). Ability to speak and present publicly.

• Strong in building and maintaining successful and effective working relationships with other colleagues in a global context.

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
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