Test Engineer for unit testing (m/f/d)

Role

Full-time

Permanent

Senior

Engineering

Logistics

Rotkreuz, Zug

100%

Requirements

3+ yrs exp

Bachelor's

EU/EFTA permit

Skills

CodebeamerJiraRoot cause analysisSolidWorksPythonAgile MethodologiesV-model developmentIVDRALM StandardsElectromechanical systems analysisFDAAccelerated Life Testing (ALT)

Languages

English

German

Description

Test Engineer for unit testing (m/f/d) – hardware testing / IVD / FDA / English / German Project: For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a qualified Test Engineer for unit testing HS/SW (m/f/d) Background: We are looking for four Senior Test Engineers (m/f/d) with a strong focus on Hardware Unit and Subsystem Testing to strengthen our 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 (FDA/MDR). 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 our 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 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.

Responsibilities

• 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.

Requirements

• 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.

Tech stack

ALM tools (Codebeamer/Jira)SolidWorksPython

Company

Itech Consult AG

Pharmaceuticals

ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering. We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.

Contact

+41 41 760 77 01