Software Test Engineer
We are looking for a seasoned Software Testing Professional within our software team to help us assure the quality of our diagnostical systems, with a focus on the software components running on that system.
You are involved in all stages of the software development lifecycle, where you define the overall test strategy, set up testing tools and methodologies, define and execute test plans, drive software risk definition and tracking and report in a structured manner on the software quality status, to all stakeholders in our company.
You work closely together with the product owner and software architect to jointly create a technical vision, guaranteeing the overall software quality, in a full end-to-end traceability setting.
Our ideal candidate has a solid experience in all phases of the software development lifecycle as a Software Test Engineer within the context of high-tech product development in a heavily regulated medical environment. Furthermore, you are a seasoned professional, and share our passion for building solutions that will shape the next generation of diagnostical solutions.
Senior software testing experience. (at least 5 years of relevant experience)
- A thorough understanding of and experience in the IVD/medical industry is mandatory.
- Experience operating within the IEC62304 norm is mandatory.
- Experience participating in regulatory submissions
- ISTQB certification is considered a strong plus
- Experience setting up full traceability between design input and output, specific to software, with a focus on software testing.
- Thorough understanding of implementing and executing test activities within the GAMP5 framework.
- Experience driving software risk assessments, tracking and mitigation.
- Excellent communication skills, ability to engage with technical teams, as well as marketing, UI/Ux, and QARA functions.
- Understanding of agile software development principles, and how to apply them within a regulated context is considered a plus.
- Experience in setting up and using Jira and Confluence supporting the SDLC process, with a focus on software quality assurance is considered a plus.
- Very strong analytical and planning skills.
- Detail-oriented, result-focused, and quality-driven.
- An excellent knowledge of English is a must (spoken and written); Knowledge of Dutch is an asset.
- You feel comfortable in a start-up environment and you can easily switch from one task to another
- You appreciate working in an open space amongst enthusiastic, multidisciplinary and international colleagues
- It is essential that you hold entitlement to work and live in Belgium