Coopers Group AG seeks a Mid-level Test Engineer in Rotkreuz to lead V&V activities for electro-mechanical medical devices, ensuring regulatory compliance through automated testing and hardware validation.
This position serves as the central contact for unit-level defects within a highly regulated medical device environment. The engineer is responsible for verifying and validating electro-mechanical hardware while configuring laboratory instrumentation to ensure strict adherence to medical device regulations.
Responsibilities
- Create, prepare, and run automated test suites, cases, and protocols to support Verification and Validation (V&V) activities.
- Perform accelerated life testing, durability assessments, and wear-and-tear evaluations to confirm long-term product reliability.
- Construct custom test fixtures, fluidic rigs, and setups by integrating sensors, pumps, and actuators, utilizing CAD tools for design.
- Develop Python automation scripts to operate test rigs and collect data, then analyze complex metrics using statistical methods.
- Investigate root causes of defects and offer design feedback to improve manufacturability (DFM/DFA).
- Partner with software, firmware, and systems engineering teams to drive continuous product improvements.
Requirements
- A degree in Mechanical, Electrical, Mechatronics, or Biomedical Engineering, or an equivalent HF Apprenticeship.
- 3 to 10+ years of practical experience in hardware testing, mechatronic unit verification, or product development.
- Demonstrated experience working in regulated medical device, In Vitro Diagnostics (IVD), or life sciences sectors (FDA/MDR).
- Proficiency with Application Lifecycle Management (ALM) systems like Codebeamer or PLM for requirement traceability, and agile tools such as Jira.
- Professional-level English proficiency, as this is the primary language for project communication.
Nice to have
- Fluency or strong understanding of German, which is advantageous or required for daily operations depending on the specific focus.
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