Failure Analysis Engineer I

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 MedTech, 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. Job Function Supply Chain Engineering Job Sub Function Quality Engineering Job Category Scientific/Technology All Job Posting Locations Danvers, Massachusetts, United States of America Job Description About MedTech 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. Purpose 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. 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 Qualifications 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 Preferred Qualifications 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 Pay Range The anticipated base pay range for this position is: $54,000.00 – $87,400.00 Benefits 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 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: Equal Opportunity Statement Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via Internal employees contact AskGS to be directed to your accommodation resource. #J-18808-Ljbffr Johnson & Johnson