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Manufacturing Engineer with Medical Device Industry

VTekis Consulting LLP

Manufacturing Engineer with Medical Device Industry

Irvine, CA
Full Time
Paid
  • Responsibilities

    Job Description

    Responsibilities:

     

    ·         Degree in Mechanical, Materials or Biomedical Engineering with minimum 4 years of experience.

    ·         Perform Gap Assessment - Equipment on the floor, Gap Assessment / review on existing change control Process & Documents.

    ·         Create / update the manufacturing procedures.

    ·         Develops and executes Engineering studies and Process validation protocols and Summary reports (Installation Qualification, Operation Qualification, Process Qualification and Test Method Validation)

    ·         Vendor Coordination to source equipment.

    ·         Perform TMV / Protocol / Execution / Report

    ·         Perform FAT.

    ·         SOP (Standard Operating Procedure) create / update as needed.

    ·         Fixture design, development and verification.

    ·         Process improvements as needed

    ·         Working independently with the internal and external stakeholders for execution.

    ·         Prepare reports, presentations, and spreadsheets of an analytical and interpretative nature.

    ·         Collaborate with peers to manage the development of appropriate testing to verify product meets internal and external customer requirements.

    ·         Maintain accountability to the completion of specific programs and projects in accordance to agreed project deliverables.

    ·         Use advanced techniques to anticipate, identify and develop solutions or alternatives to a variety of common and uncommon problems having a range of complexity.

    ·         Provide leadership, training, and mentorship to less experienced team members.

    ·         Demonstrated ability to manage and prioritize multiple tasks/projects with a strong problem-solving ability.

    ·         Adhere to safety policy procedures.

    Thanks and Regards,

    Mohammed Ilyas,

    PH - 229-264-4029

  • Qualifications

    Additional Information

    All your information will be kept confidential according to EEO guidelines.