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Engineer I Product Analysis
1 month ago
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.
Qualifications
⢠Bachelorâs 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
The base pay for this position is $48,000.00 â $96,000.00. In specific locations, the pay range may vary from the range posted.
