Senior Validation Engineer

2 hours ago


San Jose, California, United States Triunity Software Full time
Job Title: Validation Engineer

We are seeking a highly skilled Validation Engineer to join our team at Triunity Software, Inc. as a Senior Recruiter.

The ideal candidate will have a strong background in medical device manufacturing, with a minimum of 3 years of experience in test method validation and/or measurement system analysis.

The successful candidate will have a proven track record of working in a clean room environment, with experience in process and equipment qualification (IQ/OQ/PQ), development of test methods for design verification and validation, and validation of test methods.

The Validation Engineer will be responsible for executing engineering builds, gauge R&R studies, attribute analysis studies, and other validation work, as well as authoring and releasing new test methods and editing/redlining of old test methods.

The ideal candidate will have a strong understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485, with experience working in a regulated and/or medical device environment.

The Validation Engineer will work closely with our engineering team to design process validations and identify critical process parameters related to equipment working.

We offer a competitive compensation package, including $50.00 per hour, and opportunities for career growth and development.

At Triunity, we value our people and provide a challenging and friendly work environment, with opportunities to work on new edge technologies and tools, and to solve complex client problems and deliver solutions.

We are an equal opportunities employer and welcome applications from diverse candidates.



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