Senior Design Assurance Engineer

1 month ago


San Jose, California, United States CathX Full time
Job Description

Purpose of Position:

The Senior Design Assurance Engineer is responsible for ensuring the quality and integrity of CathX Medical's products. This includes designing and implementing quality assurance protocols, conducting design verification and validation, and collaborating with cross-functional teams to ensure compliance with regulatory requirements.


Key Responsibilities:

  • Develop and implement design verification and validation protocols to ensure product quality and compliance with regulatory requirements.
  • Collaborate with cross-functional teams, including R&D, manufacturing, and quality assurance, to ensure seamless product development and launch.
  • Conduct design of experiments and capability studies to optimize product performance and quality.
  • Develop and maintain quality assurance procedures and protocols to ensure compliance with regulatory requirements.
  • Support process validation and technology transfer studies to improve CathX Medical's quality assurance methodology.

Requirements:

  • Five or more years of experience in quality engineering, manufacturing engineering, and project engineering.
  • BS degree in science, engineering, or manufacturing or equivalent experience or certifications.
  • Demonstrated expertise in quality concepts, practices, and procedures.
  • Strong interpersonal skills and ability to work in a virtual or remote location.


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