General Information:
* Start date: asap
* latest Start Date: 01.09.2025
* Planned duration: 1 year
* Extension: possible (longterm project)
* Workplace: Rotkreuz
* Workload: 80-100%
* Home Office: possible, onsite work required
Background:
We are looking for someone with a technical background, ideally in electronics or medical engineering who brings experience in software and hardware testing for diagnostics instruments.
The perfect candidate has a Bachelor or Master degree in Medical Engineering, Electronics or Informatics and minimum years of experience in software and hardware testing in a highly regulated, preferably med tech environment
The candidate needs to be familiar with test planning and the basics of project management and in cross-functional product development. Experience with software tools and data bases for test management (Application Lifecycle Management tools) and test execution is required.
Tasks and Responsibilities:
* Definition of test cases for diagnostic instruments based on requirements, risk ratings and context; selection of appropriate testing methods
* Execution of tests and/or coordination of external partners for the test execution
* Contribution in the development of testing concepts and -strategies for software and hardware testing on different testing levels
* Review of requirements and specifications
* Planning, execution and documentation of all V&V- activities for system components according to internal guidelines
* Accountability for the test execution incl. standardized documentation (project- and system specific documentation compliant with internal and FDA/IVDR guidelines)
* Collaboration within the interdisciplinary development team
* Status reporting to respective project or product leader
Your Profile:
* Bachelor or Master degree in Medical Engineering, Electronics or Informatics
* At least 3 years of experience in software and hardware testing in a highly regulated environment
* Experience in a med tech environment is preferred
* Familiar with test planning and the basics of project management
* Experienced in cross-functional product development
* Familiar with software tools and data bases for test management (Application Lifecycle Management tools) and test execution
* ISTQB (International Software Testing Qualifications Board) certification is an advantage
* Networking with internal stakeholders from R&D, production, quality assurance, regulatory affairs, project management
* Fluent in English, German (Basic)
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