Your challenge in setting up the design verification test environment for the verification testing of an implantable 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 you can learn from experienced professionals in the medical device industry.
• Initial focus is on setting up the design verification test environment for the verification testing of an implantable medical device.
• Development of tests and test tooling for, mainly electrical, design verification testing.
• Management of all design verification testing activities performed both internally and externally.
• Set up a medical device design verification test environment from an equipment and tooling perspective as well as from a documentation and traceability perspective;
• Identify, select and manage external medical device test facilities;
• Manage the development and validation of design verification test systems and tooling;
• Conducts and moderates Test Plan Reviews, Test Protocol Reviews, Requirements Reviews, and Design Reviews;
• Review Design History Files and Technical Files for conformance to applicable requirements;
• Prepare, test, verify test equipment and ensure proper calibration;
• Drafting and generating written documentation in the form of specifications, engineering reports, validation plans, and validation reports;
• Provide engineering support for Process Validations, Test Method Validations, Verification and Validation strategies, protocols, reports, etc.;
• Definition and validation of test cases and test plans for electrical tests for design verification;
• Working with the project team to solve problems and identify improvements in electronics subsystems and full system.
You have a bachelor’s or master’s degree in electronics or equivalent engineering and you have relevant industry experience, preferably with active implantable medical devices.
• You have solid system and electronics testing experience within a controlled process;
• You have experience in design verification testing of medical devices, preferably implantable medical devices;
• You have understanding & experience of ISO 13485, ISO 14971;
• You have a structured way of working;
• You are a generalist, with extensive experience in design processes and testing of (medical device) electronics;
• 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 creating automated tests in Python is a pre;
• Experience in Medical Device/FDA Regulated Industry and compliance with IEC-60601, ISO 14971, ISO 14708 is a pre;
• You are fluent in English. This is our company language.
• Mastering of Dutch and/or French language is appreciated.