Senior Verification Engineer (m/f/d)

München

Medizin & Pharma

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!

Job-Infos
Berufsfelder
Qualitätsmanagement
Studienfächer
Biotechnologie
Abschluss
Master/Diplom
Unternehmen
Ingenieur-Gehälter
Was kann ich verdienen?