Hardware & Software Test Engineer (m/f/d)

• Define test cases for diagnostic instruments based on requirements, risk ratings, and usage context; selection of appropriate testing methods
• Execute test campaigns and/or coordinate external testing partners
• Develop test strategies for software and hardware components at various testing levels
• Review product requirements and technical specifications
• Plan, execute, and document all V&V activities for system components in compliance with internal and regulatory standards (e.g., FDA, IVDR)
• Ensure accurate and compliant documentation for test execution and reporting
• Collaborate closely with interdisciplinary development teams (R&D, QA, RA, PM, and production)
• Provide regular test progress updates to project or product leadership

Qualifications:
 

• Bachelor’s or Master’s degree in Medical Engineering, Electronics, or Informatics
• Minimum 3 years of experience in software and hardware testing in a regulated industry (medical devices preferred)
• Familiar with test planning, project management fundamentals, and cross-functional product development
• Experienced with test management tools (e.g., Application Lifecycle Management systems)
• ISTQB (International Software Testing Qualifications Board)  certification is a plus
• Strong communication skills and stakeholder collaboration mindset
• Fluent in English, basic proficiency in German preferred