Mechanical Engineer II

3 days ago

MA United States Johnson and Johnson Full time
Job Title: Mechanical Engineer II

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

About the Role

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

Key Responsibilities
  • Conduct complaint failure investigations and support CAPAs and engineering products.
  • 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.
  • 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.
Requirements
  • BS in Mechanical Engineering, Biomedical Engineering, or directly related scientific discipline required.
  • 3 years of relevant Post-Market work experience.
  • Proficiency with statistical tools and analysis techniques required.
  • Proficiency with analytical software such as MiniTab & Matlab is required.
  • Proficiency with Engineering CAD software 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) is required.
  • 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.
About Johnson & Johnson

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities, and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

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