Failure Analysis Engineer II

Johnson & Johnson Innovative Medicine•Danvers, MA

About The Position

We are searching for the best talent for a Failure Analysis Engineer II to be based in Danvers, MA. Purpose: The Failure Analysis Engineer II in the Post Market Engineering group plays an integral role in Abiomed’s Quality Department, conducting post-market investigations of FDA-approved medical devices. In this position, you will analyze failures of medical devices and lead CAPAs to improve the product and associated procedures. This is a position that requires an existing engineering skillset involving root cause analysis, test fixture design, and project management, but will also build a foundation of medical device and cardiology knowledge.

Requirements

BS in Electrical Engineering, Biomedical Engineering, Mechanical Engineering or directly related scientific discipline required.
Minimum of 2 years of related work experience
Electromechanical system troubleshooting experience.
Ability to interpret high-level circuit schematics, BOMs, and technical drawings.
Experience working with cross-functional teams to identify, assess, and resolve product failures.
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written).
Determination to overcome obstacles and the initiative to execute tasks in a timely manner without direct supervision.
A passion for medical devices and making a significant positive impact on the lives of our patients.
May require up to 10% travel – US & EU.

Nice To Haves

Familiarity with reverse engineering methods preferred.
Experience with process validation preferred.
Knowledge of medical device industry standards and regulations preferred.
Knowledge of capital equipment manufacturing and servicing techniques preferred.

Responsibilities

Investigate medical device malfunctions by reviewing clinical notes, examining device data logs, and analyzing the product to determine a proximal root cause.
Develop failure analysis techniques to automate testing methods and determine root causes.
Identify practical approaches to mitigate and resolve failures which will improve product reliability and patient outcomes.
Utilize statistical tools to analyze failure rates and apply risk management methodologies.
Drive CAPAs in a timely manner to prevent the re-occurrence of problems.
Coordinate changes to the product design and manufacturing or servicing procedures.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits