Failure Analysis Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Supply Chain Engineering

Quality Engineering

Scientific/Technology

Danvers, Massachusetts, United States of America

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness.

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.

• 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

• 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
• May require up to 10% travel – US & EU

• 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

The anticipated base pay range for this position is: $54,000.00 – $87,400.00

Additional Description for Pay Transparency:
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 (48 hours for Colorado residents, 56 hours for Washington residents)

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…