Our Client, a Medical Device and Healthcare company, is looking for a Product Analysis Engineer I for their Burlington, MA location.
Responsibilities:
Perform failure analysis on explanted long term biomedical implant product.
Work requires the application of theoretical principles, 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.
Aside from the 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 required; Electrical or Biomedical Engineering preferred
Engineering work experience preferred
Knowledge of global medical device reporting regulations and medical terminology preferred
Strong written and verbal communication, interpersonal, facilitation, and presentation skills required
Strong analytical, quantitative, organizational, follow-up, and attention-to-detail skills
Ability to manage multiple assignments, prioritize effectively, and meet deadlines in a fast-paced environment
Ability to work independently and collaboratively across teams and communicate effectively with all levels of employees
Demonstrated record of delivering reliability engineering insights that support management decision-making
Proficiency with personal computer applications, including spreadsheets, word processing, databases, and specialized software
Preferred candidates would have experience within post-market surveillance organizations, experience within the medical device industry, or relevant experience/coursework with both biomedical and electrical engineering.