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Job Detail
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Job Summary
Senior Quality Engineer- Transcatheter Heart Valve
Job Code: 001043
POSTED: Jan 27
Salary: Open Location: Irvine, CA
Employer: Edwards Lifesciences Type: Full Time - Experienced
Category: Quality    



Employer Information
About Edwards Lifesciences

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that save and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs about 7,000 individuals wor....more info

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Job Description

The Senior Quality EngineerWill provide Quality Engineering support for transcatheter valve system accessories new product development projects.

 

The position involves:

  • Focusing on design control
  • Failure analysis
  • FMEA
  • Specification development
  • Statistics, quality / process control
  • Acceptance sampling
  • Inspection/test methodologies
  • Process validation,

The Senior Quality Engineer will also provide the following:

  • Technical quality support for pilot production builds of clinical devices including root cause analysis investigations, addressing purchased component quality issues, complaint product evaluations, development and implementation of corrective actions, initiation and approval of product/process changes and disposition of discrepant material
  • And manage all quality-related aspects of the projects

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring.  Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that save and enhance lives.  Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs about 7,000 individuals worldwide.

 

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we help ensure that patients regain and even improve their quality of life.


Requirements
  • A bachelor of science degree in mechanical or biomedical engineering (or equivalent technical discipline) is required
  • A master's degree is preferred
  • Equipment and device qualification knowledge in the medical device industry or other highly regulated industry is required
  • Quality engineering experience in medical device product development is preferred
  • A minimum of four years experience for the Senior Engineer level
  • Must be able to effectively articulate verbally and in writing, results and conclusions to technical and non-technical personnel
  • Must have strong documentation skills
  • Must take initiative and have the ability to conduct hands-on work
  • Also, must possess the ability to handle multiple tasks with high attention to detail

 


Apply


Edwards Lifesciences
Irvine CA
http://www.edwards.com/careers