Quality Engineer - Intellectt INC

Role: Engineer

Location: Burlington, MA - 1803

Duration: 06 Months

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

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