Engineer

Position Title: Engineer I, Product Analysis

Work Location: Burlington, MA, USA

Assignment Duration: 5+ Months

Work Schedule: 8:00 AM - 4:00 PM

Work Arrangement: Onsite (100%)

Position Summary

Engineer I, Product Analysis

Key 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 organization 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, organization policies, operating procedures, processes, and task assignments.

* Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Qualification & Experience

* 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.

Working Conditions & Physical Demands

* 100% Onsite.

* Must be Local Candidate.

* Working in lab and gowned up.

Additional Information

* Preferred candidates would have experience within post-market surveillance organizations.

* Experience within the medical device industry preferred.

* Relevant experience/coursework with both biomedical and electrical engineering preferred.