Quality Engineer - Katalyst Healthcares & Life Sciences

• 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