Test Engineer for unit testing HS/SW - HW Unit & Subsystem Testing Focus

* Life Sciences - Engineering * Life Sciences - IT + Digital * Zug * Contracting * Vollzeit * 16.09.26 / latest Start Date: 01.11.26 - 1 year (with option to extend) * Testautomation, Hardware Testing / HW Testing, Verification & Validation (V&V), Python, Systemtests , Agiles Testen, Testplanning, Requirements Traceability / ALM, Software Development Life Cycle (SDLC) / V-Modell, Root Cause Analysis **Start date: 16.09.26 / latest Start date: 01.11.26** **End date: 1 year (with option to extend)** **Workload: 100%** **Contract Type: Contracting** **Location: Canton Zug** **Home Office: max. 2 days/week** **Travel: 0-10%** **Team: 5-10** **Your Profile:** * HW Unit & Subsystem Testing Focus: Revolves around the ownership of Unit Specifications (USP) and extensive Configuration & Item Management (tracking CIs and revision statuses). You will serve as the technical bridge during the integration phase, managing hardware-software dependencies. * Test Development & Execution: You will design, prepare, and execute automated test suites, test cases, and test protocols for Verification and Validation (V&V) in strict compliance with medical device regulations (FDA/MDR). * Endurance & Reliability Testing: You will develop and run accelerated life testing (ALT), durability, and wear-and-tear tests to ensure the long-term performance and reliability of hardware components under real-world conditions. * Fixture Design & Automation: You will build and assemble custom test setups, fluidic rigs, and test fixtures (utilizing CAD tools like SolidWorks) and integrate sensors, pumps, and actuators into these setups. * Scripting & Data Analysis: You will write automation scripts in Python to control test rigs and gather data, while also analyzing complex test metrics using statistical tools. * Cross-Functional Collaboration: You will conduct root cause analysis (such as 5 Whys and Fishbone diagrams) for defects, provide design feedback for manufacturability (DFM/DFA), and collaborate closely with software, firmware, and systems engineering teams on continuous improvements. **Your Profile:** * A degree (BSc, MSc, PhD, or equivalent HF Apprenticeship) in Mechanical Engineering, Electrical Engineering, Mechatronics, Biomedical Engineering, or a related discipline. * Between 3 to 10+ years of hands-on experience in hardware testing, mechatronic unit verification, or product development. * Proven expertise working in a highly regulated medical device, In Vitro Diagnostics (IVD), or life sciences environment (FDA/MDR). * Strong hands-on experience with Application Lifecycle Management (ALM) systems (such as Codebeamer or PLM) for requirement traceability, and agile tools like Jira. * Professional proficiency in English is a strict requirement as it is the project language. Fluency or a strong understanding of German is a distinct advantage or required for daily operations, depending on the focus.