Mechanical Engineer I (1 of 3) - Johnson and Johnson

Abiomed is currently recruiting for a Mechanical Engineer I to be based in Danvers, MA.

Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

Job Description:

A Mechanical Engineer 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 directly related scientific discipline required. Master's degree in an Engineering discipline
• preferred.
• No experience required. 2 years of work experience preferred.
• Proficiency with Engineering CAD software required. SolidWorks preferred.
• Proficiency with FEA and analytical software such as ANSYS Mechanical, MathCad, MiniTab & Matlab preferred.
• Knowledge of manufacturing processes such as injection molding, extrusion, machining, etc preferred.
• Ability to communicate ideas and information clearly, effectively, and frequently (oral and written)
• Determination to overcome obstacles and take initiative to execute tasks in a timely manner without direct supervision required.
• A passion for medical devices and making a significant positive impact on the lives of our patients
• May require up to 20% travel - US & EU

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.