Mechanical Engineer II

Abiomed, a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Mechanical Engineer , to be located in Danvers, Ma.

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.

Learn more at https://www.jnj.com/.

I Am Abiomed | I Am Heart Recovery | Patients First!

A Mechanical Engineer II in the Post Market Engineering group plays an integral role in Abiomed's Quality Department as a hands-on engineering role conducting post market investigations of FDA approved medical devices.

In this position you will conduct complaint failure investigations and support CAPAs and engineering products.

This is a position designed to develop a basic and broad engineering skillset to include root cause analysis, fixture design, project management, Impella product knowledge, and cardiology clinical background.

Principle Duties and Responsibilities :



* Responsible for identifying and researching failures to improve product quality and reliability.


* Develop, record and perform various failure analysis on systems and components to identify root cause.


* Establish root cause failure analysis techniques, processes and test methods.


* Develop and manage methods for tracking process failure trends based on failure analysis results.


* Function as the lead complaint investigator.

Performing complaint investigations and working with cross functional teams as needed to determine root cause, ensuring all investigations are completed in timely manner.


* Apply statistical tools to analyze data and drive problem resolution.


* Analyze failure reports and recommend corrective action to prevent re-occurrence of problems.


* Interact with device and process development engineers to assist in corrective actions and related risk assessment.


* Identify optimum analytical approaches critical to problems.


* Drive completion of all CAPAs in a timely manner


* Assist department specific subject matter experts in root cause analysis


* Investigate complaints by reviewing clinical notes, analyzing product performance data, and by inspecting and testing returned product to determine a root cause.


* Support sustaining engineering projects by proposing drawing and specification changes, modifying engineering models and drawings, designing test fixtures, conducting testing, and analyzing data


* Lead small projects and CAPAs by developing a project plan and schedule and by adhering to design controls



* BS in Mechanical Engineering, Biomedical Engineering or dire...