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Senior Validation Engineer

2 months ago


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

We are seeking a highly skilled Team Lead Validation Engineer to join our team at Triunitysoft, Inc. in San Jose, CA.

About the Role:

The successful candidate will be responsible for leading the validation team in the development and execution of test methods for Design V&V, Process Validation, and Production. This includes process and equipment qualification, validation of test methods, and execution of engineering builds, gauge R&R studies, attribute analysis studies, and other validation work.

Key Responsibilities:

  • Develop and implement validation strategies for medical device manufacturing
  • Lead a team of validation engineers in the development and execution of test methods
  • Collaborate with cross-functional teams to ensure compliance with FDA Quality System Regulation (21 CFR 820) and ISO 13485
  • Author and release new test methods and edit/redline existing methods
  • Work in a regulated and/or medical device environment to define equipment requirements, draft equipment specifications, and work on change management and releasing engineering change orders

Requirements:

  • 6 years of relevant experience in medical device manufacturing
  • Clean room environment experience
  • Experience with Test Method Validation and/or Measurement System Analysis is preferred
  • Knowledge of computer software for data analysis, specifically Microsoft Excel and statistical packages (Minitab preferred)
  • Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485
  • Strong organizational skills, detail oriented
  • Ability to collaborate within an organization across all functional departments
  • Ability to work to a deadline and handle multiple tasks simultaneously

What We Offer:

Triunitysoft, Inc. offers a competitive salary and benefits package, as well as opportunities for professional growth and development.

How to Apply:

If you are a motivated and experienced validation engineer looking for a new challenge, please submit your resume and a cover letter outlining your qualifications and experience.