Bausch Health

  • Engineer II, Mechanical

    Job Location US-MO-St Louis
    Job ID
    11325
    Pos. Category
    R&D
    Pos. Type
    Full Time
  • Overview

    Support all engineering activity for new design, design enhancements, and / or design maintenance on a medical device. Construct prototypes and test fixtures, perform tests and execute design documentation changes.  Responsible for configuration management control of all systems, modules and components used for Verification & Validation activities.  Responsible for maintaining the Engineering Lab, Environmental Chambers & Real Time Aging Room.

    Responsibilities

    Configuration Management: Responsible for maintaining configuration control of systems, modules and components used for Verification & Validation activities. Maintains configuration records for all equipment under configuration control. Maintains the Device History Record (DHR) for V&V systems. Responsible for coordinating the scheduling of V&V systems to support all R&D projects. Works with Engineering & Quality with equipment audits to ensure systems are approved for V&V testing.

     

    Verification and Testing: Build engineering prototype parts, fixtures, assemblies and modify existing parts in support of R&D development activities. Author and execute test protocols and report on results.

     

    Lab Equipment Maintenance: Responsible for the maintenance and support of lab equipment, including the Instron force tester, environmental chambers, Real Time Aging room. This includes performing preventive maintenance. Responsible for the validation of R&D lab equipment as required.

     

    Design Specification: Assemble change packages for documentation changes to Engineering Drawings, assembly BOMS, Configuration History documents, and guide packages through the approval process.

     

    Configuration Management: Responsible for maintaining configuration control of systems, modules and components used for Verification & Validation activities. Maintains configuration records for all equipment under configuration control. Maintains the Device History Record (DHR) for V&V systems. Responsible for coordinating the scheduling of V&V systems to support all R&D projects. Works with Engineering & Quality with equipment audits to ensure systems are approved for V&V testing.

     

    Verification and Testing: Build engineering prototype parts, fixtures, assemblies and modify existing parts in support of R&D development activities. Author and execute test protocols and report on results.

     

    Lab Equipment Maintenance: Responsible for the maintenance and support of lab equipment, including the Instron force tester, environmental chambers, Real Time Aging room. This includes performing preventive maintenance. Responsible for the validation of R&D lab equipment as required.

     

    Design Specification: Assemble change packages for documentation changes to Engineering Drawings, assembly BOMS, Configuration History documents, and guide packages through the approval process.

     

    Technical Leadership: Maintain Engineering prototyping lab area. Maintain calibration of test equipment.

     

    Planning, Communication and Design Control: Follow all GMPs. Communicate work priorities and job status regularly to all interested parties. Maintain work tickets. Estimate time necessary for specific design documentation changes and prototype construction activity.

     

    Key Relationships:

    Relationships with Manufacturing Engineering, R&D Engineering, Purchasing, Commercial, Manufacturing Team Leaders, Supervisors and Managers, Site Quality, and Regional Design Quality.

    Support & interact with all project teams at the St. Louis site.

     

    Scope of Position:

    Must be an effective Lead in addition to an Individual Contributor on all projects assigned.

    Qualifications

    Required Education:

     

    B.S. in Mechanical or Electrical engineering, or equivalent experience.

     

    Associates degree along with demonstrated high degree of proficiency in laboratory work may be considered.

     

    Required Skills/Qualifications:

     

    Must be familiar with Microsoft Office Professional, Document Change systems. Experience with operating lab equipment such as oscilloscopes, meters, environment chambers, force testers, machine tools.

     

    Preferred Skills/Qualificaitons:

     

    Experience with SolidWorks mCAD or Altium eCAD system. Experience with EPDM vault and Documentum systems.

     

    Required Experience:

     

    5+ years of mechanical or electrical technician experience within a structured product prototyping environment, including at least two years in a GMP-enforced environment.

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