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Manufacturing Engineer I #2685

Enhanced Compliance Inc.
Cross River State
Contract
3 weeks ago

About ECI


ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.


About the Job


Perform and execute the tasks determined for the resolutions of the different projects in which involved, ability to perform appropriately under supervision, may seek guidance in resolving problems. Demonstrate ability to be self-taught, provide creative and efficient solutions to engineering challenges to tasks assigned, follows standard practices and procedures. Participates in the completion of department projects and goals, is attentive on identifying customer needs and focus on providing solutions by being recursive, analytical and results oriented. Provides effective client satisfaction and demonstrates abilities to adapt to the culture, policies and environment when performing at a client´s company. Uses discretion, diplomacy, and tact in interactions, is flexible, respectful and maintains the confidentiality all the time. Every action must be performed with professionalism and quality compliance.


What you'll do


  • System Setup

    Assist in the setup of MES-related. Collaborate with other departments to ensure proper connections and functionality.


    MES Configuration

    Support configuration for operators.

    Participate in device pairing and testing.

    Perform initial functionality checks and escalate integration issues.


    Support for Process Mapping & Digital Work Instruction Integration

    Assist in mapping current paper-based or legacy workflows to digital equivalents in MES.

    Support the implementation of digital work instructions, ensuring clarity and usability at operator level.

    Collaborate with senior engineers to perform line walkthroughs and gather input from operators for instruction refinement.


    Testing and Validation

    Support testing and validation process under guidance, in line with FDA 21 CFR Part 11 and ISO 13485 compliance standards.

    Log and track test results; identify and document anomalies or configuration errors.

    Support dry runs and pilot tests to validate MES functionality on the floor.


    Training and Floor Support

    Provide hands-on support to operators and technicians during MES go-live periods.

    Help troubleshoot system issues and escalate problems as necessary.

    Create simple training aids (e.g., quick-reference guides, posters) under the guidance of senior engineers.


What you will bring


  • Bachelor’s Degree in Engineering.
  • 1 - 3 year of experience.
  • Advanced computer skills including MS Office applications (Word/ Excel/ PowerPoint/ Project/ Visio)
    Proficient in the use of Minitab statistical analysis.
  • Experience with SolidWorks, ProE or Inventor, prototypes, 3D (desirable)
  • Familiar with electronic management documentation.
  • Spanish: Native Speaker, English: Fluent speaking, writing and reading.

ECI is an equal opportunity employer.


All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.


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