Medical Technology Test Manager | Testmanager Medizintechnik (all gender)
ALTEN GmbH Coburg
Job Summary
As a Medical Technology Test Manager, you will lead the planning, coordination, and execution of testing activities for medical device software and embedded systems. Your daily responsibilities include designing test processes using both agile and classical methodologies while ensuring strict compliance with regulatory standards such as IEC 62304 and ISO 14971. You will utilize tools like Azure DevOps to manage test cases, document results, and maintain full traceability from requirements to final release. A key part of this role involves performing risk-based analyses (FMEA, FTA) to guarantee software safety and security. You will act as a central point of contact, collaborating closely with development, quality assurance, and regulatory affairs teams. This position is ideal for professionals who thrive in highly regulated environments and enjoy structured, compliance-driven work within a global engineering services leader that offers flexible working conditions and career development opportunities.
Required Skills
Education
University degree in Computer Science, Electrical Engineering, Medical Technology, or a comparable qualification; ISTQB Advanced Level Test Manager certification is highly preferred.
Experience
- Extensive professional experience in test management, preferably within regulated industries such as medical technology or pharmaceuticals
- Practical experience with embedded software and medical device software development lifecycles
- Proven experience working with relevant industry standards including IEC 62304, ISO 14971, and IEC 82304-1
- Experience using test management tools such as Azure DevOps or JIRA
- Experience in risk-based testing and performing safety analyses (FMEA, FTA)
Languages
Additional
- Permanent employment contract; requires the ability to work under high compliance requirements and maintain structured documentation.
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