Failure Analysis Engineer I

Johnson & Johnson • Cherry Hill, NJ

2d • Onsite

About The Position

The Failure Analysis Engineer I 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
• 1-2 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

Nice To Haves

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

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

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level