Quality Engineer
Katalyst Healthcares & Life Sciences
- Burlington, MA
- Permanent
- Full-time
- 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.
- 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