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    Senior Manufacturing Engineer - Andover, United States - TransMedics

    TransMedics
    TransMedics Andover, United States

    1 month ago

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    Description

    JOB DESCRIPTION

    Position:
    Senior Manufacturing Engineer


    Reports to:
    Manufacturing Engineering Manager

    DEPARTMENT OF MANUFACTURING ENGINEERING focuses on manufacturing of the Organ Care

    System at our headquarters in Andover Massachusetts. The team works on developing, mainaining,

    and improving manufacturing processes to support our initiavive to deliver the highest quality

    technology to save patients' lives.


    ESSENTIAL TASKS AND DUTIES:

    • Manufacturing Engineering activities associated with the production of TransMedics Organ
    Care System.


    • Work with production staff to develop manufacturing processes. Provide technical expertise
    and support related to existing and new manufacturing processes and work directly with

    production staff to improve, maintain, and provide support to such processes.


    • Work hands on to develop manufacturing processes, participate in validation activities, data
    collection and analysis of production process.


    • Complete continuous improvement project initiatives focused on improving product quality
    and reducing cost.


    • Provide mentorship and training to Jr level engineers and interns.

    Creation of documentation including:
    Manufacturing Instructions, Inspection procedures, Test

    Protocols, Assembly drawings, equipment control documentation, and Component Drawings.


    • Lead activities with the Engineering and Operations teams to identify opportunities to
    streamline production through process improvements, test improvements, and product design

    changes.


    • Work with cross functional teams to identify and resolve technical and quality related issues
    including participation in MRB, customer complaint investigations, CAPA related activities,

    design activities, and regulatory submissions.


    • Serve as strong team player, supporting and assisting supervisor and colleagues when
    necessary and comply with all work safety rules and regulations.


    • Perform other TransMedics tasks and duties as required.

    BACKGROUND AND QUALIFICATIONS:

    • 8+ years of experience working in an FDA/ISO regulated Medical Device/ Medical Equipment
    Industry


    • Must have prior Process Development and/or Manufacturing Engineering experience including
    the development and execution of Process Validations to support new and existing process

    and test equipment.


    • Must have prior experience leading the design, development, and validation of production
    fixtures and tooling.


    • Previous experience working directly with production staff to improve manufacturing
    processes.


    DocuSign Envelope ID:
    B313FCCE-7775-4BBE-960F-64C45B794A313


    • Must have prior work experience leading the development of plastic assembly, hardware
    assembly, electromechanical assembly, and test processes and validations.


    • Ability to work with Solidworks, and/or Pro Engineer to create 3D models and drawings to
    support manufacturing assembly models, fixture design and development, and sustaining

    engineering activities.


    • Experience using Minitab or similar statistical evaluation software/tools, Lean Six Sigma
    experience and knowledge of statistical data analysis techniques is a plus.


    • Experience leading Root Cause Investigations and CAPAs.
    • Proven track record of working in a fast-paced environment with demonstrated ability to adjust
    to changing priorities.


    • Must have ability to identify, prioritize, and resolve issues as they arise with minimal
    supervision. Must possess a strong work ethic, effective oral and written communication skills,

    and excellent interpersonal skills.


    EDUCATION:
    BS in Engineering plus 8+ years of experience working in an FDA/ISO regulated Medical

    Device/ Medical Equipment Industry, or equivalent education and years of experience

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