Will participate in formalized product test design, review, execution, and reporting.
Will perform structured testing, generate defect findings, and participate in rigorous technical assessments.
Will be responsible for generating evidence used to demonstrate compliance with applicable global regulatory standards.
Must be goal-oriented and very proactive in problem solving.
Must be an eager and fast learner that is capable of accepting and dealing with dynamic program changes, including schedule changes.
Must be flexible and adaptable in satisfying the needs of assigned programs.
Must be able to read and follow test instructions, write clear and comprehensive test instructions, and have a very high degree of technical competence, comprehension, and proficiency.
Must be able to analyze test results and make subsequent recommendations.
To succeed in this role, you’ll need a customer-first attitude and the following
Minimum 5 - 10 years of overall experience
Strong technical understand of, and ability to use, common laboratory equipment (i.e., oscilloscopes, function generators, power supplies, etc.).
Software application test experience within a regulated environment is desired.
Programming or scripting experience is highly desirable (Powershell, bash/command line, Python, C/C++, C#, etc.).
High proficiency in MS Windows and MS Office.
Must be able to function with minimal supervision.
Demonstrated ability to interact effectively and collaboratively within a team setting.
Demonstrated ability to work equally well within a team and independently.
Strong written and verbal communication skills.
Bachelor’s or equivalent degree in a technical, engineering, or scientific field.
Experience with automation or automation testing is a plus.
Related experience in the medical device industry is highly desirable.
Knowledge of an FDA-regulated development environment is highly desirable.
Knowledge of ultrasound systems is highly desirable.
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