Engineer I, Product Analysis

ICONMA, LLC

Burlington, MA

JOB DETAILS
SALARY
$36.20–$40.04 Per Hour
SKILLS
Analysis Skills, Biomedical Engineering, Biomedicine, Communication Skills, Corporate Policies, Cross-Functional, Detail Oriented, Electrical Engineering, Environmental Management Systems, Establish Priorities, FDA (Food and Drug Administration), FDA Requirements, Failure Analysis, Follow Through, Health Plan, Healthcare, Implants, Manufacturing, Medical Equipment, Medical Terminology, Mentoring, Multitasking, Operations Processes, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Product Development, Product Engineering, Quality Management, Regulations, Regulatory Requirements, Surveillance, Test Equipment, Time Management, Writing Skills
LOCATION
Burlington, MA
POSTED
2 days ago
Our Client, a Medical Devise and Healthcare company, is looking for an Engineer I, Product Analysis for their Burlington, MA location.
 
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.
 
Requirements:
  • 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
 
Why Should You Apply?

About the Company

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ICONMA, LLC