Demo

Engineer

TekOne IT Services Pvt. Ltd.
Burlington, MA Contractor
POSTED ON 1/16/2025
AVAILABLE BEFORE 3/11/2025
Role: Engineer

Location: Burlington, MA (Locals Preferred)

Duration: 06 Months

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.
  • 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.

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
  • 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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