Test Engineer for unit testing HS/SW - Fluidics Component Focus

Coopers Group AG seeks a Senior Test Engineer in Rotkreuz to lead V&V activities for next-generation Blood Gas & Electrolytes analyzers, focusing on fluidic components and automated testing.

This position is tasked with planning, developing, and executing verification and validation processes for medical diagnostic systems. The primary objective is to guarantee the quality, reliability, and safety of upcoming Blood Gas & Electrolytes (BG/E) analyzers through rigorous testing protocols.

Responsibilities

• Perform tightness, stress, and endurance tests on fluidic consumables.
• Create and run automated test suites, cases, and protocols for Verification and Validation (V&V) in line with FDA and MDR regulations.
• Conduct accelerated life testing (ALT) and durability assessments to verify long-term product performance.
• Construct custom test setups, fluidic rigs, and fixtures using CAD software such as SolidWorks.
• Assemble and integrate sensors, pumps, and actuators into testing configurations.
• Develop Python scripts to automate test rig operations and collect data.
• Analyze test metrics using statistical methods to identify trends and issues.
• Investigate defects through root cause analysis techniques like 5 Whys and Fishbone diagrams.
• Offer design feedback to improve manufacturability (DFM/DFA).
• Work closely with software, firmware, and systems engineering teams to drive continuous improvements.

Requirements

• A degree (BSc, MSc, PhD) or equivalent HF Apprenticeship in Mechanical, Electrical, Mechatronics, Biomedical Engineering, or a related field.
• 3 to 10+ years of practical experience in hardware testing, mechatronic unit verification, or product development.
• Demonstrated experience in regulated medical device, In Vitro Diagnostics (IVD), or life sciences sectors (FDA/MDR).
• Strong knowledge of fluidic components (valves, connectors) and measurement equipment.
• Proficiency with Application Lifecycle Management (ALM) systems like Codebeamer or PLM for requirement traceability.
• Professional-level English proficiency is mandatory.

Nice to have

• Fluency or strong understanding of German.
• Experience using agile tools such as Jira.

What the company offers

• Possibility to extend the initial 1-year fixed-term contract.
• Option to work from home up to 2 days per week.