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 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.