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Biomedical Engineer
1 week ago
Failure Analysis Engineer
Duration: 5-month contract - possible extension/conversion
Location: Onsite in Burlington, MA
Start: 2-weeks from an offer
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.
Qualifications:
• Bachelor’s Degree in Engineering; Biomedical or Mechanical Engineering is preferred
• Knowledge of global regulations for medical device reporting and medical terminology is a positive
• Strong written and oral communication skills are required
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