Senior Design Quality Engineer

3 weeks ago


Northridge, California, United States Medtronic Full time
Job Description

We are seeking a highly skilled Senior Design Quality Engineer to join our team at Medtronic. As a key member of our quality team, you will be responsible for ensuring the design and development of our medical devices meet the highest quality standards.

Key Responsibilities:

  • Apply design for reliability and manufacturability (DRM), design for six sigma (DFSS), and design for manufacturing assembly (DFMA) methodologies to ensure high-quality product design.
  • Develop and implement process failure modes effects analysis (PFMEA) and hazard analysis to identify and mitigate potential risks.
  • Collaborate with cross-functional teams to develop and implement process parameters, input-process-output (IPO) matrices, and process characterizations.
  • Utilize statistical techniques and data analysis to inform design decision-making and drive process improvements.
  • Navigate government and industry standards, including FDA QSR, ISO13485, ISO14971, and EU Medical Device Regulations.

Requirements:

  • Master's degree in mechanical engineering, biomedical engineering, or related field.
  • At least two years of experience in manufacturing or quality engineering for medical devices.
  • Strong knowledge of DRM, DFSS, DFMA, PFMEA, hazard analysis, and FMEAs.
  • Excellent communication and collaboration skills.

About Medtronic:

Medtronic is a global leader in medical technology, committed to improving the lives of patients worldwide. We are passionate about innovation, collaboration, and making a meaningful impact on healthcare.



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