Software Test Lead
Belgium, Vlaams Gewest, LeuvenSoftware
We are looking for a seasoned software testing professional within the software team to help us assure the quality of our diagnostical systems, with a focus on the software components running on that system. You will be 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 will work closely together with the product owner(s) and software architect to jointly create a technical vision, guaranteeing the overall software quality, in a full end-to-end traceability setting. You will also have experience in working with third parties to, where, required, bolster test resourcing and interaction with suppliers.
You'll lead a diverse and globally distributed team of software test engineers, providing mentoring, coaching, and review of the work of your team.
The ideal candidate has 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 industry, such as automotive, oil, or - preferentially - the medical device or in vitro diagnostic field. Furthermore, you have a passion for a high integrity work ethic and will share our values for building products and services that will shape the next generation of health care diagnostic solutions.
Your tasks will be:
- Lead various test teams in the general workstreams of embedded firmware, PC, and off-PC-based technologies.
- Coaching and mentoring of team members on testing and operating within the 62304 norm
- Spokesperson, evangelist, and single-point-of-contact for all topics related to software QA, for the broader company.
- Review and update templates for software V&V test plan, software integration test plan, software CI test plan (one per software CI), possibly templates for associated test reports, test readiness plan/report and possibly requirements <> test traceability report template.
- Create formal test plans and reports, based on established company generic templates.
- Where necessary author and review test cases along with test team members, taking a lead role so to coach and mentor while maintaining test case standards as defined in the test plans and 62304.
- Where applicable, test case execution
- Implement automated tests, where appropriate
- Lead validation activity of all software tools using in formal development and V&V activities.
- Create any and all formal test reports for later submission to project management
- Be able to positively contribute to technical and project meetings, as required, to provide V&V guidance where needed. '
- Senior software testing experience. (5y+)
- Experience as a team lead (5y+), with a solid understanding of people management principles, is necessary.
- 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 a formally regulated and controlled environment, such as GAMP5.
- 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 using project control, software, and test artifact and reporting systems such as Jira, SpiraTeam, and Confluence is considered a plus.
- Very strong analytical and planning skills.
- Detail-oriented, result-focused, and quality-driven.
- You must be entitled to live and work in Belgium (no work / residence permit needed).
- Fluency in English