Senior Test Engineer - HW Unit & Subsystem (m/f/d)

Poste

Durée déterminée

Senior

Ingénierie

Modalités

Rotkreuz, Zoug

100%

Exigences

5+ ans d'exp.

Bachelor

Permis UE/AELE

Compétences

Accelerated Life Testing (ALT)PythonSolidWorksConfiguration managementRoot cause analysisData TraceabilityAgile MethodologiesMedical Device ReportingCodebeamerTest Pack DevelopmentVerification engineeringBatch Scripting

Langues

Anglais

Allemand

Description

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. 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.

Responsabilités

Test Development & V&V Execution: 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).
Subsystem & Unit Ownership: Take ownership of Unit Specifications (USP) and lead extensive Configuration & Item Management (tracking CIs and revision statuses).
Integration & Technical Bridge: Serve as the core technical bridge during the integration phase, actively managing hardware-software dependencies and cross-functional interfaces.
Endurance & Reliability Testing: Develop and run Accelerated Life Testing (ALT), durability, and wear-and-tear protocols to validate long-term product reliability.
Fixture Design & Automation: Build custom test setups using SolidWorks CAD, integrating sensors, pumps, and actuators, and write Python automation scripts for test rig control and data acquisition.
Root Cause Analysis: Conduct systematic root cause analyses (5 Whys, Fishbone diagrams) for defects and provide actionable DFM/DFA design feedback.

Exigences

Degree (BSc, MSc, PhD, or HF) in Mechanical Engineering, Electrical Engineering, Mechatronics, Biomedical Engineering, or a related field.
5+ years of hands-on experience in hardware testing, mechatronic unit verification, or product development.
Proven expertise working in a highly regulated medical device or In Vitro Diagnostics (IVD) environment (FDA/MDR).
Strong background in Requirement Traceability using ALM tools (e.g., Codebeamer) and Agile methodologies (Jira).
Practical experience with custom test fixtures (SolidWorks), Python automation scripting, and statistical data analysis.
Language Skills: Professional proficiency in English is required (project language). German comprehension is a distinct advantage.

Technologies

SolidWorksPythonALM toolsJira

Avantages

Become part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare.
Experience a work culture that promotes diversity and inclusion and where all employees feel valued.
Work on a state-of-the-art campus featuring green spaces, meeting areas, and an inspiring atmosphere.
Work with modern and up-to-date tools in an innovative work environment.
Start with a professional onboarding process and a thorough introduction to your new role during the Welcome Days.
Benefit from financial support for your professional development plans.
Enjoy a selection of high-quality meals in modern staff restaurants.
As part of a sustainable mobility concept, on-site parking spaces are available to you.
Take advantage of unbeatable, year-round discounts at renowned retailers and over 200 top brands.
Benefit from fleet discounts when purchasing new cars or receive constant fuel discounts.

Entreprise

Work Selection

Pharmaceuticals

As a first-tier supplier to our renowned business partner Roche Diagnostics in Rotkreuz, we are currently looking for a motivated and dedicated Senior Test Engineer - HW Unit & Subsystem for a temporary assignment of 1 year, with a high probability of extension.