Katalyst CRO

Product Design Verification and Stability Engineer

San Antonio, TX, US

4 months ago
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Summary

Responsibilities

  • Plan and execute design verification/stability engineering projects and reliability activities to support the development of safe and reliable medical devices.
  • Develop and validate test methods, write protocols based on defined requirements, and provide clear and concise test reports.
  • Perform data analysis activities including tolerance intervals, Ppk, data reduction, and gage repeatability and reproducibility.
  • Apply design for reliability (DFR) concepts (DFMEA, HALT, FTA, etc.) during the product development process to ensure that designs are intrinsically reliable.
  • Assist engineering team in failure investigations/ root cause analysis for problems identified during lab testing and field issues.
  • Opportunity to work in the challenging and rewarding medical device industry.
  • Collaborate with some of the most innovative and diverse people around the world.
  • Develop and qualify new test protocols, ensuring that test objectives are effectively incorporated.
  • Assist engineers in the compilation and analysis of basic reliability data from field studies.

Requirements

  • Bachelor's degree in engineering (Mechanical, Biomedical, Electrical, or other).
  • Two or more years engineering experience in medical device (or other regulated industry) using reliability testing or design.
  • Engineering project management experience.
  • Understanding of fundamental reliability concepts life data analysis, etc.
  • Working knowledge of analog and digital electronics. Ability to troubleshoot, improvise, and work from schematics.

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