Quality Engineer

Responsibilities:

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.

Requirements:

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