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    Medical Device Engineer - Buffalo, United States - CivicMinds, Inc

    CivicMinds, Inc
    CivicMinds, Inc Buffalo, United States

    5 days ago

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    Description

    Job: Sr. Medical Device Engineer

    Location: Buffalo, NY (Direct Hire)

    Job Summary: Plans, designs, and develops production processes for single-use medical devices, ensuring compliance with customer specifications and company procedures.

    Job Duties:

    • Leads customer projects, managing schedules and resources for successful project execution.
    • Coordinates development activities internally and with customers to meet deadlines.
    • Translates customer needs into engineering specifications and manufacturing processes.
    • Ensures regulatory compliance with FDA, ISO, and other standards.
    • Identifies materials, designs tooling, and optimizes production for volume, cost, and quality.
    • Prepares engineering documents and oversees product testing/validation.
    • Designs and validates manufacturing tooling, equipment, and processes.
    • Maintains engineering documents and stays updated on industry trends and technologies.
    • Assists sales in estimating materials and labor for quotations.
    • Mentors new Product Engineers.
    • Demonstrates company values of honesty, integrity, and respect.
    • Performs other duties as assigned.

    Skills/Technical Skills:

    • Strong communication and teamwork skills.
    • Proficiency in Microsoft Office, Solidworks, and related software.
    • Experience with Lean Manufacturing/6 Sigma methodologies.
    • Knowledge of injection molding, ultrasonic welding, or radio frequency welding.

    Knowledge:

    • Familiarity with regulatory environments (FDA, FAA, ISO
    • Preferred knowledge of medical device manufacturing and world-class manufacturing.

    Experience:

    • 4+ years of related experience.
    • Experience in regulated environments.
    • Familiarity with production line layout and process validations.

    Education:

    • Bachelor's degree in Mechanical, Plastics, Biomechanics, or Biomedical Engineering.
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