SolidWorksPythonRoot cause analysisData TraceabilityData AnalysisIntegration testingfluid engineeringSecure Software Development Lifecycle (Secure SDLC)Automated test suitesCE-IVDValidation PlanningVerification engineering
Languages
EnglishGerman
The role
03
Your tasks:
Fluidics Component Focus: Centers around fundamental fluid mechanics, you will heavily execute tightness, stress, and endurance testing on fluidic consumables.
Test Development & Execution: You will design, prepare, and execute automated test suites, test cases, and test protocols for Verification and Validation (V&V) in 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.
01Fluidics Component Focus: Centers around fundamental fluid mechanics, you will heavily execute tightness, stress, and endurance testing on fluidic consumables.
02Test Development & Execution: You will design, prepare, and execute automated test suites, test cases, and test protocols for Verification and Validation (V&V) in compliance with medical device regulations (FDA/MDR).
03Endurance & 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.
04Fixture 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.
05Scripting & 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.
06Cross-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.
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).
↳Expertise with fluidic components (valves, connectors) and measurement equipment.
↳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.
