Location: Indianapolis, IN
The Validation Test Engineer performs and documents the validation test activities for a successful medical device developer and manufacturer.
Writing and execution of test protocols and reports.
Identify equipment/fixture installation qualification requirements.
Interact with a cross-functional team of engineers, clinicians, technicians, and quality controllers to determine test requirements.
Compare specifications with listed requirements for design, risk control, and standards.
Maintain traceability of requirements to the test records in the quality system.
Provide support for quality and engineering projects.
BS Degree in technology, (e.g., biomedical, engineering) or similar technical background.
Strong communication and technical writing skills for protocol and report generation is required.
Ability to analyze and interpret technical documentation and standards.
Hands-on familiarity with general tools and equipment, their setup and maintenance.
Basic knowledge and experience of statistics, test methods, validation principles, and DOE.
Ability to test software, electrical systems, and processes.
Experience with medical device design and development is a plus.
Time management and prioritization skills.
Sonablate is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.