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?
Ähnliche Ingenieur-Jobs
- HITZLER INGENIEUREFachprojektmanager:in Medizintechnik (m/w/d)bundesweitBiotechnologie
- Löwenstein Medical SE & Co. KGVerification Engineer Quality (m/w/d) MedizintechnikHamburgBiotechnologie +3
- Ziehm ImagingSenior Hardwareentwickler – FPGA & Embedded Systems für Medizintechnik (m/w/d)NürnbergBiotechnologie +3
- Löwenstein Medical SE & Co. KGVerification Engineer Quality (m/w/d) MedizintechnikHamburgBiotechnologie +3
- gempexQualifizierungsingenieur (m/w/d) (GMP/Pharma/Life Sciences)MannheimBiotechnologie +3
Weitere Jobs
get in Engineering hat die Informationen von der Webseite des Unternehmens und ggf. sonstigen Quellen sorgfältig zusammengestellt. Diese Informationen wurden vom Unternehmen noch nicht autorisiert.Informationen für Unternehmen