Softworld Mechanical Analysis Engineer in Danvers, Massachusetts
Mechanical Analysis Engineer
Employment Type: Contract
Job Number: 233947
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
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