LivaNova
80331 München - Deutschland
Ingenieur/in - Biotechnologie
Arbeit
Vollzeit
ab 01.03.2026
Beschreibung
## General Responsibilities
- Develop and implement robust verification strategies for software-driven electromechanical medical devices at subsystem and system levels.
- Lead the creation, review, and optimization of reusable test cases and verification protocols, ensuring alignment with regulatory standards (FDA, MDR).
- Design and develop test fixtures and test benches based on design input requirements to support automated and manual testing.
- Drive the development and integration of test ... weiter lesen
- Develop and implement robust verification strategies for software-driven electromechanical medical devices at subsystem and system levels.
- Lead the creation, review, and optimization of reusable test cases and verification protocols, ensuring alignment with regulatory standards (FDA, MDR).
- Design and develop test fixtures and test benches based on design input requirements to support automated and manual testing.
- Drive the development and integration of test ... weiter lesen
## General Responsibilities
- Develop and implement robust verification strategies for software-driven electromechanical medical devices at subsystem and system levels.
- Lead the creation, review, and optimization of reusable test cases and verification protocols, ensuring alignment with regulatory standards (FDA, MDR).
- Design and develop test fixtures and test benches based on design input requirements to support automated and manual testing.
- Drive the development and integration of test automation frameworks and tools to improve efficiency and coverage.
- Create and manage detailed verification schedules, ensuring timely execution and reporting of results.
- Perform statistical analysis, sample size justification, and test method validation to support verification activities.
- Collaborate closely with cross-functional teams (systems, software, hardware, clinical) to ensure comprehensive risk and safety mitigation.
- Provide technical leadership and mentorship to junior engineers, fostering a culture of excellence and continuous improvement.
- Coordinate verification activities across multiple teams and projects, ensuring consistency and compliance with internal and external standards.
- Contribute to the development and maintenance of documentation for regulatory submissions.
- Support the evolution of the V&V framework and best practices across the organization.
## Skills and Experience
- Master’s degree in (medical) engineering, software engineering, or a related technical field.
- Several years of experience in software and system verification, preferably within the medical device industry.
- Proven experience in test design, test execution, and anomaly reporting.
- Test bench or test fixture design, maintenance, improvement, and extension.
- Strong analytical, conceptual, and problem-solving skills.
- High documentation standards for preparing required V&V documentation aligned with regulatory standards (FDA, MDR).
- Hands-on experience with automated requirements and test management tools (e.g., Polarion, DOORS).
- Proficiency in test automation tools and scripting (e.g., Python, CAPL, VTestStudio).
- Experience with CAN-Bus communication and Vector tools.
- Familiarity with regulatory standards such as IEC 60601-1, IEC 62304, and 510(k) submissions is a plus.
- Excellent communication skills in English (spoken and written); German is a strong plus.
- Self-motivated, proactive, and capable of working independently and in teams.
- Travel 5%
## What we can offer you
In addition to providing you with a supportive, inclusive and collaborative environment where you will feel empowered to take ownership and drive meaningful change, we will reward you with the following:
- A dynamic role in an advanced Medical Device environment interfacing with all worldwide regulatory landscapes supporting your professional career growth
- Exposure to a *State-of-the-Art* medical device development process, in close co-operation with international clinicians
- Competitive base salary
- Variable short-term & long-term incentives
- Recognition: through our STARS Program, we recognize and celebrate our colleagues’ contributions and achievements
If you like the sound of the above and feel energized by the idea of joining a great brand at a moment of exciting expansion, please apply now. We look forward to hearing from you!
- Develop and implement robust verification strategies for software-driven electromechanical medical devices at subsystem and system levels.
- Lead the creation, review, and optimization of reusable test cases and verification protocols, ensuring alignment with regulatory standards (FDA, MDR).
- Design and develop test fixtures and test benches based on design input requirements to support automated and manual testing.
- Drive the development and integration of test automation frameworks and tools to improve efficiency and coverage.
- Create and manage detailed verification schedules, ensuring timely execution and reporting of results.
- Perform statistical analysis, sample size justification, and test method validation to support verification activities.
- Collaborate closely with cross-functional teams (systems, software, hardware, clinical) to ensure comprehensive risk and safety mitigation.
- Provide technical leadership and mentorship to junior engineers, fostering a culture of excellence and continuous improvement.
- Coordinate verification activities across multiple teams and projects, ensuring consistency and compliance with internal and external standards.
- Contribute to the development and maintenance of documentation for regulatory submissions.
- Support the evolution of the V&V framework and best practices across the organization.
## Skills and Experience
- Master’s degree in (medical) engineering, software engineering, or a related technical field.
- Several years of experience in software and system verification, preferably within the medical device industry.
- Proven experience in test design, test execution, and anomaly reporting.
- Test bench or test fixture design, maintenance, improvement, and extension.
- Strong analytical, conceptual, and problem-solving skills.
- High documentation standards for preparing required V&V documentation aligned with regulatory standards (FDA, MDR).
- Hands-on experience with automated requirements and test management tools (e.g., Polarion, DOORS).
- Proficiency in test automation tools and scripting (e.g., Python, CAPL, VTestStudio).
- Experience with CAN-Bus communication and Vector tools.
- Familiarity with regulatory standards such as IEC 60601-1, IEC 62304, and 510(k) submissions is a plus.
- Excellent communication skills in English (spoken and written); German is a strong plus.
- Self-motivated, proactive, and capable of working independently and in teams.
- Travel 5%
## What we can offer you
In addition to providing you with a supportive, inclusive and collaborative environment where you will feel empowered to take ownership and drive meaningful change, we will reward you with the following:
- A dynamic role in an advanced Medical Device environment interfacing with all worldwide regulatory landscapes supporting your professional career growth
- Exposure to a *State-of-the-Art* medical device development process, in close co-operation with international clinicians
- Competitive base salary
- Variable short-term & long-term incentives
- Recognition: through our STARS Program, we recognize and celebrate our colleagues’ contributions and achievements
If you like the sound of the above and feel energized by the idea of joining a great brand at a moment of exciting expansion, please apply now. We look forward to hearing from you!
Ref-Nr.: 7938220
Aktualisiert:
28.03.2026
Quelle: Bundesagentur für Arbeit
weitere Infos Rechtliche Hinweise zur Nutzung
Ob die Stelle noch verfügbar ist und weitere Informationen findest du direkt auf der Website der Bundesagentur für Arbeit. Bitte beachte: OPROMA ist nicht der Anbieter dieser Stelle und kann keine Auskünfte geben.
weitere Infos Rechtliche Hinweise zur Nutzung
Ob die Stelle noch verfügbar ist und weitere Informationen findest du direkt auf der Website der Bundesagentur für Arbeit. Bitte beachte: OPROMA ist nicht der Anbieter dieser Stelle und kann keine Auskünfte geben.
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