Within GTX medical we are developing a Therapy with the aim to let paralyzed people walk again. We are a young innovative start-up company with young enthusiastic (software) engineers highly committed to develop a first-generation product. The capabilities of those products are life-changing for our intended patients; to recover from their spinal cord injury. Despite the structure everybody is approachable and helpful to make your contribution successful and meaningful.
Excited to work in a high-tech environment and work on a therapy that can be life-changing for paralyzed people? Check our vacancy and apply now.
As a Software Quality Assurance Engineer you will be part of the GTX medical software team that designs, develops and implements a class III implantable medical device for electrical spinal cord stimulation with in and out body parts.
The type of work will vary throughout the phases of the project. Within this context, you contribute to the software teams on quality related activities by being hands-on. We strive for high quality software products being developed within an agile environment where we do not want to enforce this by excessive procedures, although some procedures are required in our regulated medical device industry like the IEC:62304.
• Collaborate with the software teams and conduct quality related activities like:
o Software configuration management
o Release management
• Safe guard compliancy to the applicable software standards and our Quality Management System (QMS). Non-compliances and improvements resulting from audits are being implemented by you;
• Assess and conduct the software tool validation program according to the risk level of the identified software tooling;
• Managing some tooling being part of our software development infrastructure;
• Create reports regarding the use of 3rd party software being used in our products, so called SOUP reporting;
• Conduct consistency checks on our deliverables (e.g. requirement- and test-traceability);
• In the spirit of an innovative start-up company many other small activities may cross your desk to meet and exceed our dynamic company goals;
• Report and align your activities to the Software Architect.
• You have a Bachelor or Master’s degree;
• You have a background in software development (+4 years in the industry);
• You have experience as a Software Quality Assurance Engineer (+2 years);
• You have experience in the medical domain, and knowledge of the EN:62304 is highly appreciated;
• You understand what it takes to work in a regulated environment;
• You are a self-starter with an agile mindset and a can-do mentality.