Leading verification and validation activities for regulatory submission according to ISO 13485 with focus on software-driven electromechanical components at sub-system and system level
Efficient planning and coordination of test activities and its required resources
Active participation in change-, release- and defect management
Writing, reviewing and execution of verification test protocols by selecting and using effective tools, methods and applicable test standards
Create test equipment and fixtures including design of hardware and/or software
Perform testing activities and data analysis using needed statistical techniques
Developing test method validations
Write and release final verification reports and verification summaries
Evaluate timeline for assignments and track/communicate progress for testing tasks
Write engineering test documentation
Your Skills:
Master’s Degree in Electrical, Mechanical or Medical Engineering or related disciplines or comparable background
At least 5 years of experience in similar roles, preferably accrued in medical devices companies
Working knowledge of requirements engineering and risk management
Experience on leading solutions related to testing for Electrical and Mechanical design
Good experience with test management tools such as Polarion, Doors, etc.
Experience with CAN-Bus communication, PCAN Explorer and statistics software is a plus
Experience with Vector tools like CANoe, CAPL, VTestStudio is a plus
Capability to assess accuracy and precision of test methods
Understanding of safety critical environments
Experience in IEC 60601-1 and IEC 62304 is a plus
Possesses methodical documentation skills
Good troubleshooting skills
Self-Starter, self-motivated, hands-on person
Ability to work within teams and contribute to success
Fluency in English (written and spoken), German language is a plus
START: ASAP
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