Hardware Test Engineer, Medical Devices (Unit & Subsystem)

Gi Group; Risch-Rotkreuz; Vor Ort; CHF 110.000 - 160.000; Vollzeit

Zusammenfassung

Roche Diagnostics Rotkreuz seeks a Test Engineer specializing in unit testing for HS/SW hardware units and subsystems. The role involves designing automated tests, validating V&V processes under FDA/MDR, and collaborating across software, firmware, and systems teams to ensure safety and performance of BG/E analyzers.

You will work on measurement chamber, fluidics, oximetry, and HW unit subsystems, with hands-on hardware testing and lab instrumentation in a regulated environment.

Qualifikationen

• 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, IVD, or life sciences environment (FDA/MDR)
• Strong hands-on experience with 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

Aufgaben

• Test Development & Execution: design, prepare, and execute automated test suites and protocols for V&V under medical device regulations (FDA/MDR).
• Endurance & Reliability Testing: develop and run ALT, durability, and wear tests for hardware components.
• Fixture Design & Automation: build test fixtures and fluidic rigs; utilize SolidWorks for CAD.
• Scripting & Data Analysis: write Python scripts to control test rigs and analyze test metrics.
• Cross-Functional Collaboration: perform root-cause analysis (5 Whys, Fishbone) and support DFM/DFA with software/firmware teams.
• Measurement Chamber Focus: evaluate electro-mechanical hardware and lab instrumentation; primary contact for unit defects.
• Fluidics Component Focus: test fluidic components and conduct tightness and endurance tests on consumables.
• Oximetry Focus: physical testing of precision hardware, oscillators/optics; handle biological samples in BSL-2.
• HW Unit & Subsystem Testing Focus: own USP and tracking of CIs/revisions; bridge integration between hardware and software

Kenntnisse

Python scripting

Data analysis

Hardware testing

Ausbildung

BSc/MSc/PhD in Mechanical, Electrical, Mechatronics, Biomedical Engineering or related

Tools

SolidWorks

CodeBeamer

PLM

Oscilloscopes

Jobbeschreibung

Roche Diagnostics Rotkreuz seeks a Test Engineer specializing in unit testing for HS/SW hardware units and subsystems. The role involves designing automated tests, validating V&V processes under FDA/MDR, and collaborating across software, firmware, and systems teams to ensure safety and performance of BG/E analyzers.

You will work on measurement chamber, fluidics, oximetry, and HW unit subsystems, with hands-on hardware testing and lab instrumentation in a regulated environment.