Setting up and execution of design verification tests for a medical device.
You will be part of the Go-2 project team developing a first-of-its-kind active implantable medical device (AIMD) system for spinal cord stimulation, with the aim to let paralyzed people regain voluntary control of locomotion.
GTX medical is a fast-growing start-up where you will have the opportunity to take initiative, responsibility and contribute to innovation, while at the same time learn from experienced professionals in the medical device industry.
The type of work will vary throughout the phases of the project.
• Initial focus is on setting up the design verification test environment for the verification testing on system and component level testing of a medical device
• Development of tests and test tooling for components and system design integration and verification testing
• Set up a medical device test environment from an equipment and tooling perspective as well as from a documentation and traceability perspective;
• Development and execution of integration and verification test systems including tooling;
• Definition of test cases and test plans for integration and verification tests;
• Conducts Test Plan Reviews, Test Protocol Reviews, Requirements Reviews, and Design Reviews;
• Review Design History Files and Technical Files for conformance to applicable requirements;
• Manage and validate tooling and test methods;
• Prepare, test, verify test equipment and ensure proper calibration:
• Generate tool specifications, engineering reports, tool and test method validation plans, and validation reports
• Provide engineering support for Verification and Validation strategies, protocols, reports, etc.;
You have a bachelor’s or master’s degree in electronics, mechatronics or equivalent engineering, and you have relevant industry experience (2+ years), preferably with medical devices.
• You have solid experience in system and component testing within a controlled process;
• You have hands-on experience in design verification testing preferably medical devices;
• You have hands-on experience in Python
• You are a generalist, with experience in design processes and testing of medical device (electronics, mechanics);
• You have a system thinking attitude, can identify areas of potential improvement and develop plans to address these;
• You are a high energy, self-motivated, pro-active individual able to work in a diverse team within a startup company;
• Experience in Medical Device/FDA Regulated Industry and compliance with ISO 13485, ISO 14971 is an advantage;
You are fluent in English. This is our company language.
Proficiency in Dutch and/or French language is appreciated.