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Quality Assurance Engineer (Software)

Logo for ArdenVent

Your Impact When we walk into a hospital we all assume that we can trust the medical devices literally with our lives. However, ensuring that such reliability is justified is hard work. In many developing countries this type of trust is not at all obvious. It is our dream that those who need treatment can have trust in the medical industry regardless of where they live. In this position, you will be helping us to achieve exactly that. You will:

Improve the safety and reliability of the device Provide context on the intended use and possibilities of misuse help us achieve FDA and MDR approval Your Responsibilities

Work with the Risk Manager, software Engineers, and Medical Professionals to specify device requirements Write verification/validation plans in compliance with -FDA requirements Review and write requirement documents Review design documents Plan and organize hardware tests and trials Requirements

Significantly involved in compliance work on a medical device with successful FDA submission or equivalent experience in another high-quality industry 1+ year professional experience in software engineering can read and understand C++ Code, ideally can code as well expertise in using Test Driven Development (TDD) or Behaviour Driven Development (BDD) ideally, experience with GitHub actions and continuous integration tools ideally, experience with Test Management using XRay and Jira Desired Skills

[Legal (General)]

[Software Engineering, C++ Programming, Embedded Systems, Medical Devices, FDA / MDR Submissions, Quality Control, Quality Assurance/Testing, Risk Management]

Core Competencies [Decision Making, Teamwork, Focus, Planning and organizing, Oral Communication, Written Communication, Time management, Responsibility, Commitment]