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West Boylston

    Process Automation Engineer - West Boylston, United States - ZealoTech People

    ZealoTech People
    ZealoTech People West Boylston, United States

    3 weeks ago

    Default job background
    Upper Management / Consulting
    Description

    Job Overview:

    A provider of turnkey manufacturing services for medical OEMs, is seeking a skilled and experienced Operations Process Engineer (OPE) to join our team. The OPE will play a crucial role in providing leadership and support to manufacturing operations in our FDA & ISO 13485 regulated medical device manufacturing facility.

    2.0 Responsibilities:

    2.1 Development and Optimization of Manufacturing Processes:


    • Lead the development and optimization of manufacturing processes from inception through start-up, validation, and full-scale production.


    • Utilize Certified SolidWorks Professional Mechanical Design (CSWP) proficiency to contribute to detailed design and product development.

    2.2 Engineering Analysis and Process Improvement:


    • Perform engineering analysis of process performance, identifying opportunities for improvement with a focus on safety, efficiency, and risk mitigation.


    • Utilize statistical techniques and tools like Minitab to enhance manufacturing quality.

    2.3 Continuous Improvement and Lean Manufacturing:


    • Lead and support Continuous Improvement activities, including Kaizens, process improvements, and structured problem-solving events.


    • Design and plan cell layouts for Operational Excellence using lean manufacturing tools and techniques.

    2.4 Process Validation and Project Management:


    • Lead or support engineering functions during IQ, OQ, PQ process validations.


    • Provide project management and technical support for plantwide process improvement projects.

    2.5 Qualifications:

    2.5.1 Essential Requirements:


    • Master of Science in Mechanical Engineering; BSME or related engineering discipline.


    • Exp of Manufacturing/Process engineering experience.


    • Proficiency in SolidWorks, AutoCAD, CREO, and simulation tools, including Finite Element Analysis (Abaqus, ANSYS) and SolidWorks Simulation.


    • Experience in a FDA-regulated environment, including knowledge of ISO 13485 and FDA regulatory requirements.

    2.5.2 Additional Qualifications:


    • Certified SolidWorks Professional Mechanical Design (CSWP).


    • Experience with machine-based repetitive manufacturing, including automation and controls.


    • Familiarity with RF welding desirable.


    • Experience using DFMA methodologies and developing tools/fixtures for process optimization.


    • Knowledge of controlled environment protocols.

    2.6 Skills:


    • Excellent written and verbal communication skills.


    • Strong analytical and interpersonal skills.


    • Ability to lead and motivate team members.


    • Methodical, organized, and able to manage multiple projects concurrently.


    • Proficient in MS Office tools, including Word, Excel, Visio, MS Project, Access, and PowerPoint.

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