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)

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

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. 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.

The Perfect Candidate holds a relevant engineering degree (BSc, MSc, PhD, or HF) and brings 3 to 10+ years of hardware testing and product development experience within highly regulated IVD or medical device environments (FDA/MDR). They combine hands-on expertise in requirement traceability using ALM tools (like Codebeamer) and Jira with deep technical skills to design custom test fixtures (SolidWorks), execute automated V&V protocols, and run accelerated endurance testing (ALT). Furthermore, this candidate excels at writing Python automation scripts for test rigs, analyzing complex data metrics, and driving continuous improvement through rigorous root cause analysis (5 Whys, Fishbone) and cross-functional collaboration on DFM/DFA. Professional English is mandatory, with strong German skills serving as a distinct advantage.

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:

• 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.

Reference Nr.: 925107SDA
Role: Test Engineer for unit testing (m/f/d)
Industrie: Pharma
Workplace: Rotkreuz
Pensum: 100%
Start: 01.10.2026

Duration: 12++
Deadline: 29.07.2026

If you are interested in this position, please send us your complete dossier. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:

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.

ITech Consult AG
+41417607701