Test Engineer for unit testing HS/SW

Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are based here. For our long-standing client, Roche Diagnostics International AG in Rotkreuz, we are looking for an

Background:

We are looking for a Senior Test Engineer with a strong focus on Hardware Unit and Subsystem Testing to strengthen the cross-functional engineering team. In this role, you will be the driving force ensuring the quality, robustness, and reliability of hardware units to ensure their seamless integration into the system level.

We are seeking experienced Test Engineers (5+ years) with a strong background in HW/SW testing within highly regulated medical or IVD environments. You possess a deep understanding of the V-model and are proficient in ALM/Agile tools (Codebeamer/Jira).

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

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

Tasks & Responsibilities:

• 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

Individual Tasks & Responsibilities per profile:

• 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.

Must Haves (across all four profiles):

• 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

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