ISO 13485 Jobs in Germany

In this role, you will analyze security requirements for software projects, collaborate on data protection concepts, and support the implementation of legal regulations in healthcare while working closely with development teams.

In this job, you will specify the system architecture for medical devices, implement customer and regulatory requirements, and coordinate the development between hardware and software with a focus on usability.

In this role you design and implement verification and system tests for electromechanical medical devices, plan and document test campaigns to MDR/FDA standards, analyze results statistically and coordinate test environments.

You support software teams on privacy and IT security, design role/right and identity management concepts, validate healthcare regulations (e.g. SGB V, MDR), assess risks, assist audits and maintain QM/compliance documentation.

In this role, you provide technical support for medical analysis devices, perform maintenance and repairs, install systems, train users nationally and internationally, address complaints, and develop solutions for issues.

In this role, you will lead complex medical device product development projects, manage cross-functional teams, and ensure all processes comply with regulatory standards and quality requirements.

In this role, you will lead quality assurance in development projects, ensure compliance with standards, conduct audits, and support quality management through comprehensive risk analyses and document reviews.

Design of software solutions in the development of software for medical devices. Develop and implement mathematical/bioinformatics algorithms. Software development, requirements analysis, risk management, software verification, software release,...

Design of software solutions in the development of software for medical devices. Develop and implement mathematical/bioinformatic algorithms. Software development, requirements analysis, risk management, software verification, software release, software...

Planning, maintenance and further development of our Microsoft Windows environment. Identity and rights management in Active Directory. Shared responsibility for the virtualization environment (VMware vSphere). Monitoring of the infrastructure as well...

Quality management support for medical devices throughout the entire product life cycle. Collaboration in interdisciplinary teams in the development and modification of Löwenstein Medical Technology products. Preparation of plans for the verification of...

Leading engineering activities for regulatory submission according to ISO 13485 with focus on software-driven electromechanical components at sub-system and system level. Efficient planning and coordination of test activities and its required resources....