Software System Engineer for Medical Devices (m/w/x)

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ZEISS employees work in an open and modern environment with numerous development and further training opportunities. Our culture is characterized by expert knowledge and team spirit. All this is supported by the special ownership structure and the long-term goal of the Carl-Zeiss Foundation: to advance science and society together.

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We are looking for an experienced software system engineer who takes responsibility for the software system of complex medical devices in ophthalmology and drives their development, partly together with hardware development.

Responsibility for the software system of complex medical devices.

Technical management of software concepts, planning, implementation and verification of software solutions in embedded systems taking into account the software strategy.

Central technical interface to global research and development sites, knowledge transfer, standardization and promotion of synergies between products and solutions.

Definition of software system specification in cooperation with product management, usability development, hardware development, production, service and quality department.

Supporting the project managers to achieve an optimal time-cost-quality ratio.

Responsible for the requirement management at system and software level

Ensuring the cyber security of the software system in cooperation with software architects and cybersecurity experts

Support for risk analysis and implementation of the measures defined in the software system

Professional responsibility within the framework of authorisation

Continuous process improvement

Supporting external development partners

University or university degree in the field of software engineering, computer science or information technology.

Multiannual professional experience, ideally in the regulated environment

Advanced knowledge of professional software development.

Experience with ALM Tools (e.g. Polarion)

Knowledge of requirements engineering and system modeling (e.g. UML).

Experience in systems engineering and the development of embedded systems.

Confidence with approach models of software development.

Knowledge of regulatory standards such as FDA regulations, ISO 13485 and IEC 62304.

Understanding risk management processes (ISO 14971).

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