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Softworld Mechanical Analysis Engineer in Danvers, Massachusetts

Mechanical Analysis Engineer

Danvers, MA


Posted: 01/04/2021

2021-01-04 2021-02-21

Employment Type: Contract

Industry: Engineering

Job Number: 233947

Job Description

Job Description

Need a hands-on engineer to conduct 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 will utilize broad engineering skillset, including 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 corrective and preventive actions 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 by developing a project plan and schedule and by adhering to design controls

Job Qualifications:

BS in Mechanical Engineering, Biomedical Engineering or directly related scientific discipline required.

  • 2-5 years of work experience.

  • 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 the initiative to execute tasks in a timely manner without direct supervision