Validation Engineer

Sunnyvale, CA 94089

Employment Type: Direct Category: Manufacturing Engineer Job Number: 9129

Job Description

As a Validation Engineer, you will strategically contribute to improving healthcare through faster, more accurate diagnostic tests. You will enable the expansion of the current manufacturing supply capacity, reduce cycle time, improve yield and product quality.  You will make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us, every moment of every day, to develop rapid groundbreaking solutions for the world’s most complex health challenges.

Qualifications:

  • Bachelor or Master of Science in Mechanical Engineering, Material Science, Bioengineering, Manufacturing Engineering or Industrial Engineering
  • SolidWorks, AutoCAD, MS Office
  • Experience in manufacturing or quality engineering in a medical device/consumables manufacturing environment
  • Strong familiarity in Validation and Verification process (V&V)
  • Experience designing, documenting, and executing product and/or process validation and qualification
  • Demonstrated experience in mechanical testing and troubleshooting of components and final product
  • Demonstrated experience in high-volume manufacturing of injection-molded parts for medical consumables preferred
  • Familiar with FDA regulatory compliance requirements for medical devices, ISO 13485, 21 CFR Part 820

Responsibilities:

 

  • Coordinate engineering testing, first article inspections, and qualification activities for validation and verification of consumables components
  • Maintain and/or improve existing consumables parts production, with an emphasis on improving manufacturability, achieving cost reductions, and enhancing throughput
  • Communicate with external tooling and molding vendors regarding design and development, qualification, or repair activities
  • Assist in failure investigations and root cause analyses as they relate to consumables part performance in high-speed automation environments.
  • Carry out high standards for all consumables products such that the design intent, quality expectation for patient safety, and finished medical device function are never compromised

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