Test Engineer for unit testing HS/SW (a)

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 in Rotkreuz (ZG), a global leader in in vitro diagnostics, we are looking for a motivated individual with strong focus on Hardware Unit and Subsystem Testing

Test Engineer for unit testing HS/SW (a)

You will play a pivotal role in shaping the next generation of Blood Gas & Electrolytes (BG/E) Analyzers, ensuring our medical diagnostic devices meet the highest standards of safety and efficacy. This collaborative, high-impact position is located at our site in Rotkreuz, Switzerland, and offers the flexibility to tailor responsibilities to your unique strengths.

We are hiring across four specialized profiles corresponding to our functional units: Measurement Chamber, Fluidics Component, Oximetry, and HW Unit & Subsystem.

• 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.
• Measurement Chamber Focus: Deep involvement in evaluating electro-mechanical hardware (currents, voltages, clamping forces) and configuring lab instrumentation like encoders and oscilloscopes. You will act as the primary point of contact for unit defects in Operations or the BSL-2 lab.
• Fluidics Component Focus: Centers around fundamental fluid mechanics, requiring expertise with fluidic components (valves, connectors) and measurement equipment. You will heavily execute tightness, stress, and endurance testing on fluidic consumables.
• Oximetry Focus: Demands physical testing on precision hardware, specifically mechanical oscillators and optics. You will evaluate microfluidic chips and perform biological sample preparation (such as handling whole blood and adjusting hematocrit levels) safely inside a BSL-2 laboratory.
• 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.
• 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