Manufacturing Engineer - Covina - Quanta US

    Quanta US
    Quanta US Covina

    10 hours ago

    $70,000 - $120,000 (USD) per year *
    Description

    An established global medical device manufacturer is seeking a Senior Manufacturing Engineer to lead high-impact process improvements, support new product introductions, and drive quality and reliability in a regulated production environment.

    This is a highly visible role within a growing, innovation-driven organization whose products directly support critical healthcare and transfusion applications.

    Do you have the skills to fill this role Read the complete details below, and make your application today.

    What You'll Do

    • Lead complex manufacturing projects from concept through implementation
    • Drive quality, cost, and efficiency improvements across production processes
    • Own out-of-box and early-life product performance for a key product line
    • Execute and document process validations (IQ/OQ/PQ)
    • Lead or support Lean / Six Sigma / Kaizen initiatives
    • Conduct and maintain dFMEA / pFMEA and risk management documentation
    • Ensure compliance with ISO 13485, ISO 14971, EU MDR, and FDA 21 CFR
    • Support design transfer, scale-up, and new product introduction
    • Partner cross-functionally with R&D, Quality, and Operations

    What We're Looking For

    • Bachelor's degree in Engineering (Biomedical, Mechanical, Chemical, Materials, or similar)
    • 5+ years of manufacturing engineering experience in an FDA-regulated industry
    • Experience in medium-to-high volume manufacturing environments
    • Strong background in process validation and continuous improvement
    • Experience with statistical tools (Minitab, JMP)
    • Familiarity with CAD (SolidWorks or Pro/E preferred)
    • Knowledge of ISO 13485 and ISO 14971
    • Transfusion or blood-handling device experience highly preferred

    Why Consider This Role? xhmxlyz

    • Direct impact on patient safety and product reliability
    • Strong cross-functional exposure and leadership visibility
    • Opportunity to influence design-for-manufacturability and scale-up strategy
    • Stable, global organization with continued investment in innovation

    If you're an experienced manufacturing engineer who thrives in regulated environments and enjoys solving complex process challenges, I welcome a confidential conversation.

    * This salary range is an estimation made by beBee
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