Reliability Engineer

1 month ago


Milpitas, California, United States TEPHRA Full time
Job Title: Reliability Engineer - Process Optimization

We are seeking a highly skilled Reliability Engineer to join our team at TEPHRA. As a key member of our engineering team, you will be responsible for ensuring the reliability and quality of our products.

Key Responsibilities:
  • Review and develop quality plans and risk management plans to ensure provisions for quality are addressed and resolved prior to product release.
  • Work with R&D and project teams to develop, review, and approve verification plans for new designs and changes to released products.
  • Perform statistical analysis of data and provide technical support for testing.
  • Assess reliability in bench, lab, and clinical settings, producing full traceability of reliability assessment evidence to performance measures, metrics, and requirements.
  • Develop reliability growth and verification test plans, accelerated testing methods, statistical data analysis methods, and test equipment concepts to support product and subsystem reliability growth and evaluation.
  • Review and approve changes to designs and processes, assessing their impact on product and qualification status.
  • Ensure team compliance with relevant safety regulations, QSRs, ISO Standards, MDD, and key FDA/MDD guidance documents.
  • Ensure technical documentation meets requirements of regulations such as ISO 13495 and FDA CFR820.
Requirements:
  • B.S. in Engineering.
  • Minimum 4 years of experience in Reliability Engineering, with 2+ years of experience working with medical device products and in the healthcare industry.
What We Offer:

At TEPHRA, we offer a dynamic and challenging work environment, with opportunities for professional growth and development. We are committed to excellence and innovation, and we are seeking a talented and motivated individual to join our team.


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