Quality Engineer

2 weeks ago


Burlington, United States Katalyst HealthCares & Life Sciences Full time
Responsibilities:
  • Perform failure analysis on explanted long-term biomedical implant product.
  • Work requires the application of theoretical principals, evaluation, ingenuity, and creative/analytical.
  • Must be able to meet deadlines on multiple assignments and be able to operate in a diverse cross-
  • Proactive in finding quality improvements related to Failure Analysis
  • May serve as lead and assign work to less experienced personnel
  • Works cross functionally and collaboratively with Product Development, Engineering, Manufacturing,
  • Aides in definition of test equipment as required to accomplish quality responsibilities.
  • Support all Company initiatives as identified by management and in support of Quality Management
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements,
  • Maintains positive and cooperative communications and collaboration with all levels of employees
  • Perform failure analysis on explanted biomedical implant product. Provide technical expertise to the
  • Product Analysis Laboratory. Analyzes failures, develops, and implements investigative protocols to
  • identify root causes, performs circuit analysis, performs device and component level failure analysis.

Requirements:

  • Bachelor's Degree in Engineering is Required
  • Biomedical or Mechanical Engineering is preferred
  • Engineering work experience is preferred
  • Knowledge of global regulations for medical device reporting and medical terminology is a positive
  • Strong written and oral communication skills are required
  • Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously
  • Multitasks, prioritizes, and meets deadlines in a timely manner
  • Strong organizational and follow-up skills, as well as attention to detail


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