Engineer I, Product Analysis (Electronics Lab)

Role: Engineer I, Product Analysis (Electronics Lab)

Location: Burlington, MA

Experience: 0-1 years (Entry level)

PayRate: $25-30/hr on W2

100% Onsite - Must be Local Candidate (Need to be available for Onsite interview)

This is an entry-level Post Market role which will handle complaint

investigations Will be a combination of office and lab work with 1/3 desk work

and 2/3 lab work Will require PPE/Gowning: Head and beard covers, shoe covers,

gloves, mask, etc. Will be working with deadlines and cross-functional teams A

Bachelor's degree in Engineering (Electrical or Biomedical is preferred)

Engineering work experience is preferred for up to one year preferably - can

have 2 years of experience but no more than that Master's Degree is fine but No

PhDs please Ideal Candidate is one who has done Co-op or Internship Will extend

and/or convert based on performance and budget Top Skills: 1) Time Management

1. Strong Communication - verbal and Technical Writing 3) ability to multi-task,

work independently and with other teams

Main Purpose of Role

• Perform failure analysis on explanted biomedical implant product. Provide technical expertise to the Product Analysis

• Laboratory. Analyzes failures, develops, and implements investigative protocols to identify root causes, performs circuit

• analysis, performs device and component level failure analysis.

Main 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

• 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.