Engineer

About the role

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.

Responsibilities

• 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 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

Pay & Schedule

• Pay: $44 - $47 per hour
• Duration: 6 months
• Location: Burlington, MA (100% Onsite, working in lab and gowned up)
• Local candidates required