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    Manufacturing Engineer II - Westbrook, United States - Axelon

    Axelon
    Axelon Westbrook, United States

    4 weeks ago

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    Description
    Job Title: Manufacturing Engineer II
    Location: Scarborough, ME
    Shift Timings: 8 AM - 5 PM (Monday through Friday)

    Responsibilities:
    • Develop processes, specify equipment, acquire and implement it.
    • Identify root causes of manufacturing failures using structured problem-solving techniques and implement fixes to prevent recurrence.
    • Troubleshoot equipment by evaluating machine logic, electromechanical systems, and process controls.
    • Conduct design experiments, validations, tests, and data analysis for continuous improvement projects, and present findings to equipment teams.
    • Propose and support new methods or materials to improve quality and efficiency.
    • Analyze current equipment for process suitability and create detailed improvement plans.
    • Create and update manufacturing documents, SOPs, safety instructions, validation protocols, and technical documents to ensure compliance and safety.
    • Collaborate with engineers and technicians to develop solutions and improvements in materials, equipment, and processes.
    • Participate in teams to ensure continuous improvement, safety, and compliance.
    • Provide training and expertise in process development, tooling, and validation.
    • Manage engineering project teams and mentor junior engineers and technicians.
    • Initiate and resolve Quality Incidents and CAPA.
    • Ability to travel up to 25% of the time.
    Basic Qualifications | Education:
    • Bachelor's degree (BS) in engineering or equivalent experience.
    • Minimum three years of engineering experience in a manufacturing environment.
    • Familiarity with material testing and measuring methods.
    • Proficiency in Database, CAD, Development, Internet, Inventory, Manufacturing, Project Management, Microsoft Excel, and Microsoft Word software.
    Preferred Qualifications:
    • Experience in GMP, FDA, ISO, and USDA regulated environments.
    • Familiarity with cGMP and ISO 13485 regulations.
    • Experience with statistical analysis software (e.g., Minitab).
    Competencies:
    • Ability to work with mathematical concepts such as ANSI/AQL, probability, and statistics.
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