Test Engineer for unit testing HS/SW - Oximetry Focus Zug

Coopers Group AG seeks a Test Engineer in Rotkreuz to verify and validate medical diagnostic systems, focusing on Blood Gas & Electrolytes analyzers through hardware testing and automation.

This position is dedicated to the planning, development, and execution of verification and validation activities for medical diagnostic equipment. The primary objective is to guarantee the quality, reliability, and safety of Blood Gas & Electrolytes analyzers through rigorous testing protocols.

Responsibilities

• Conduct physical testing on precision hardware components, including mechanical oscillators and optical systems.
• Evaluate microfluidic chips and prepare biological samples, such as whole blood with adjusted hematocrit levels, within a BSL-2 laboratory setting.
• Create and execute automated test suites and protocols for Verification and Validation, ensuring strict adherence to FDA and MDR medical device regulations.
• Perform accelerated life testing and durability assessments to verify long-term hardware performance under realistic conditions.
• Construct custom test fixtures, fluidic rigs, and setups using CAD tools like SolidWorks, integrating sensors, pumps, and actuators.
• Develop Python automation scripts to control test equipment and collect data, utilizing statistical tools for metric analysis.
• Investigate defects using root cause analysis methods like 5 Whys and Fishbone diagrams, providing design feedback for manufacturability and collaborating with engineering teams.

Requirements

• A degree in Mechanical Engineering, Electrical Engineering, Mechatronics, Biomedical Engineering, or a related field, or an equivalent HF Apprenticeship.
• 3 to 10+ years of experience in hardware testing, mechatronic unit verification, or product development.
• Demonstrated experience in regulated medical device, In Vitro Diagnostics (IVD), or life sciences environments, specifically with FDA/MDR compliance.
• Professional proficiency in English, as it is the required project language.

Nice to have

• Fluency or strong understanding of German, which is advantageous or required for daily operations depending on the specific focus.

What the company offers

• Option to work from home for a maximum of 2 days per week.