Quality Engineer - Intellectt INC
Burlington, MA
About the Job
Hello Everyone,
Greetings of the day.
This is Vydehi from Intellectt Inc. We currently have an opening for a Engineer with one of our medical device clients. If you or anyone you know is interested in this opportunity, please feel free to send your updated resume to vydehi@intellectt.com or reach out to me directly at +1 732 355 7412.
Role: Engineer
Location: Burlington, MA
Duration: 06 Months
Main Purpose of Role:
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.
Main Responsibilities:
Perform failure analysis on explanted long-term biomedical implant product.
Work requires the application of theoretical principals, evaluation, ingenuity, and creative/analytical techniques to identify route cause failure mechanisms.
Must be able to meet deadlines on multiple assignments and be able to operate in a diverse cross-functional team environment.
Proactive in finding quality improvements related to Failure Analysis
May serve as lead and assign work to less experienced personnel and serves as a mentor when assisting less experienced lab staff in solving more complex problems.
Works cross functionally and collaboratively with Product Development, Engineering, Manufacturing, and Product Surveillance.
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 Systems (QMS),
Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Education:
Qualifications:
Bachelor's Degree in Engineering is Required
Electrical or Biomedical Engineering is preferred
Engineering work experience is preferred
Knowledge of global regulations for medical device reporting and medical terminology is a positive