ISO 14971 Job 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 will lead quality assurance in development projects, ensure compliance with standards, conduct audits, and support quality management through comprehensive risk analyses and document reviews.

In this role, you will oversee software quality throughout the entire product lifecycle, control testing processes, and handle risk management and technical documentation in the medical technology sector.

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...

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...

Lead or participate in Design Control (DC), Usability Engineering (UE) and Risk Management (RM) within product development projects in accordance with the local quality management system. Draft, review, and approve DC, RM, and UE documentation according...

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

Core member of product development in interdisciplinary teams for the development of networked medical devices or software for the operating room. Close cooperation with R&D to ensure successful development and risk management. Ensuring the highest...

QM moderator and motivator for software development from embedded to innovative cloud applications: You are happy to assist the development team with quality-related questions and tasks. This absolutely important part of your job and responsibility can...

In your role as Design Quality Engineer (Software) (m/f/d) you will be working as a part of product development teams to ensure the quality and reliability of products, while minimizing risks to patients, with a specific focus on software for medical...