Are you the experienced System/Electronics Test Manager who would like to contribute to the design, development and implementation of a class III implantable medical device for electrical spinal cord stimulation?
What you will do
The type of work will vary throughout the phases of the project. Your initial focus will be on setting up the design verification test environment for the verification testing on system and component level testing of a medical device. You will develop tests and test tooling for, mainly electrical, design verification testing. Furthermore, you are responsible for the test management of all design verification testing activities performed both internally and externally.
Responsibilities include but are not limited to:
- 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;
- Conduct and moderate 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;
- Draft and generate written documentation in the form of test plans, test specifications, engineering reports, tool validation plans, and tool validation reports;
- Provide engineering support for Test Method Validations and Verification strategies, protocols and reports;
- Define and validate test cases for electrical tests for design verification;
- Work with the project team to solve problems and identify improvements in electronics subsystems and full system.
What we are looking for:
- You hold a bachelor’s or master’s degree in electronics or equivalent engineering;
- You have multiple years’ system and electronics testing experience within a controlled process and experience in design verification testing of medical device electronics, preferably active implantable medical devices;
- You have experience in Medical Device/FDA Regulated Industry or other highly regulated environment (IEC-60601, ISO 13485, ISO 14971, ISO 14708);
- Experience in creating automated tests in Python is preferred;
- You have a structured way of working and system thinking attitude, can identify areas of potential improvement and develop plans to address these;
- You are an energetic, hands-on individual and enjoy working in an international, cross-functional environment within a young and growing company;
- You communicate fluently in English as this is our company language; proficiency in French and/or Dutch language is highly appreciated;