Engineer

Title: Engineer

Location: Burlington, MA

Duration: 4 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.
• 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

• 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