Senior Verification Engineer
LivaNova
Munich, Germany
Position Summary
We are seeking a highly experienced Senior Verification Engineer to join our dynamic and international R&D team in Munich. You will play a pivotal role in a top-priority, cross-disciplinary new product development initiative focused on a cutting-edge Heart-Lung Machine used for life support during cardiac surgery. This device integrates complex software and hardware functionalities, requiring rigorous verification at both subsystem and system levels.
This position offers a unique opportunity to shape the future framework of requirements engineering and V&V activities across all R&D projects in Munich, with a clear path toward leadership roles.
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%
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