Insulet Corporation

Project Engineer, Systems COE

Job Locations US-MA-Billerica | US-MA-Billerica
Posted Date 2 weeks ago(2/5/2018 5:42 PM)
Category
Engineering / Program Management

Position Summary

This position will be integral in determining the design of disposable, software and hardware class II and class III medical devices by supporting all phases of the Design Control Process.  The person in this position will be required to design, execute and report on engineering tests, for feasibility and product verification, as well as author Product Specification and Risk Assessment documentation.  This role must have a strong mechanical/manufacturing/project engineering background with the ability to quickly understand electro-mechanical assemblies.

Responsibilities

  • Support all phases of the Design Control Process.
  • Design and set up feasibility tests in a lab environment.
  • Author product qualifications test and report results.
  • Author Engineering Change Orders.
  • Author work order requests and be responsible for tracking product builds for test.
  • Provide documentation verifying component or device function and maintain documentation control prior to controlled release.
  • Assist in the procurement of device components that meet specification.
  • Participate in product design reviews.
  • Design iterations of the product.
  • Contributes to team effort by accomplishing related results as needed.
  • Perform other duties as required.

Education and Experience

  • Bachelors of Science in Engineering (Biomedical/Mechanical/Manufacturing); minimum of 1-5 years’ work experience as a Biomedical/Mechanical/Project Engineer in the Medical Device or other regulated industry and/or equivalent combination of education and experience.
  • Demonstrate working knowledge of Mechanical Engineering and Design.
  • Demonstrate working knowledge of Project Management, Risk Management and Design Control methodologies.

 

 Skills and Competencies

  • Effective verbal and written communication skills.
  • Ability to communicate at multiple levels of an organization.
  • PC skill, word processing, spreadsheet, database.
  • Ability to organize and judge priorities.
  • Ability to generate and maintain accurate records.
  • Experience working with medical devices a plus.
  • Familiarity with SPC, and GD&T a plus.
  • CAD Experience (Pro-Engineer, Solidworks) a plus.

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