This role contributes to all phases of development of Medical Device products, starting with research and development through product development and manufacturing. The candidate must have a solid base of test engineering knowledge and applicable skills to develop and perform a wide variety of tests. The Test Engineer will support product development and Quality Assurance by developing test methods and performing tests according to approved protocols. Testing will vary from quick proof-of-principle requiring minimal documentation to detailed product design verification testing. Communication and organization skills are essential traits due to the number of concurrent projects.
- Test Method Development: Develop rigorous, reliable test methods based on the testing needs provided by the Engineering and Quality Assurance teams.
- Test Fixture Design: Develop and document test fixtures, including selection of appropriate measurement instrumentation, mechanical design, electrical design, and data logging. Test fixtures must be documented appropriately, based on the level of testing to be performed according to FDA regulations.
- Test Method Validation: Where required, validate test fixtures and methods for use in verification testing or manufacturing.
- Testing: Rigorously follow test methods, utilizing test equipment in a safe and repeatable manner, and record data accurately.
- Test Reporting: Generate concise, accurate test reports with clear indications of the results.
- Test Equipment and Methodology: Possesses a broad understanding of a variety of test and measurement equipment. Understands various methods for measuring physical parameters and the factors that are critical for accurate measurements.
- Test Fixture Design: Has the ability to combine mechanical, electrical, and software elements to produce testing apparatus capable of measuring physical properties to the required level of precision. Understands the process of documenting the design such that it can be produced effectively.
- Good Documentation Practices: Effectively documents all aspects of testing from test equipment use to test procedure to test results.
Experience and Qualifications
- Minimum of a Bachelors degree in Engineering
- Minimum of 2 years direct test engineering experience, preferably in an FDA regulated environment, or 4 years of product development that includes testing
- Mechanical or Electrical Engineering background preferably with experience in cross-disciplinary work including software.
- Understanding of basic principles of measuring force, pressure, temperature, and air flow. Exposure to a variety of test and measurement equipment.
- Working knowledge of basic statistics
- Familiarity with Good Documentation Practices