Experience: 4+ years in product/core reliability engineering (Medical device/MedTech domain only)
Responsibilities
Work with R&D, quality assurance, and manufacturing teams to develop reliability requirements and create comprehensive reliability test plans for IVD medical devices that align with product development and production processes.
Lead and facilitate Design Failure Mode and Effects Analysis (DFMEA).
Design and develop test methods and fixtures to assess the performance and durability of IVD devices.
Write test protocols, train personnel on test procedures, analyze data, and create final reports.
Conduct reliability tests, including environmental, lifecycle, and accelerated aging tests, to evaluate product performance under different cond...