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Billerica

    Sr. Manufacturing Engineer - Billerica, MA, United States - Primary Talent Partners

    Primary Talent Partners
    Primary Talent Partners Billerica, MA, United States

    3 weeks ago

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    Description
    Primary Talent Partners has an 8-month Sr. Manufacturing Engineer contract opening with a Fortune 500 Medical Device client based out of the Billerica, MA area. Pay is $50 to $60 per hour based on overall experience.


    Please note:
    You will be sitting on a W2 with Primary Talent Partners at an hourly basis without PTO/Benefits - We cannot provide sponsorship or accept C2C, OPT, or 1099 candidates

    Job Description:

    We are looking for a dedicated Manufacturing Engineer with expertise in medical devices or regulated industries to lead and support various process improvement and remediation activities.

    The ideal candidate will possess strong problem-solving abilities, a solid understanding of lean manufacturing and six sigma principles, and hands-on experience in process development and validation.


    Responsibilities:
    Lead and support process improvement and remediation activities, including fixture design, procurement, installation, and validation.
    Conduct process mapping, development, and time studies, along with line layout optimization.
    Set up labeling systems, update documentation, and ensure compliance with regulatory standards.
    Perform process validation activities (IQ/OQ/PQ) and author engineering protocols and closing reports.
    Update documentation in the PLM system (BOM, SOP, visual aids, drawings, work instructions).
    Conduct root cause analysis, measurement system analysis, gemba walks, and update PFMEA and control plans.
    Support Non-Conforming Material Reports (NCMRs), CAPAs, and audit findings resolution.
    Provide weekly reports, updates, and perform administrative tasks as needed.
    Conduct testing and provide manufacturing and engineering support as required


    Minimum Requirements:
    Bachelor of Science Degree in Mechanical Engineering, Packaging Science, or similar discipline.

    Minimum of 5 years of experience in the medical device or pharmaceutical industry in Manufacturing Engineering, Packaging, or Quality Engineering.

    Practical knowledge and demonstrated competence within manufacturing engineering, process development, and packaging engineering.
    Experience with lean manufacturing and six sigma practices.
    Knowledge and general understanding of ISO 11607 part 2, ASTM, and ISTA package test methods preferred


    Product Line Support:
    Cardiac Ablations Solutions, cardiac mapping and navigation systems, and catheter-based cardiac ablation technologies. Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

    If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at #PTPJobs #LI-PTP
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