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40 uur - GTX medical

Sr. Design Verification Engineer

Vacature details


Your challenge in setting up the design verification test environment for the verification testing of an implantable medical device.

Candidate challenge

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.

Candidate responsibilities

• 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.

Candidate profile

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.

Vacature details
  • Electronics
  • Design Verification Testing
  • Class III Medical Device System
  • Start-up environment
  • Multidisciplinary Engineering Team
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