Manufacturing Engineer - St Paul - Intellectt Inc

    Intellectt Inc
    Intellectt Inc St Paul

    2 days ago

    $70,000 - $120,000 (USD) per year * Pharmaceutical / Bio-tech
    Description

    Hiring for Manufacturing Engineer - Medical Device / Regulated Manufacturing in St Paul, Minnesota,

    Industry: Medical Device / Regulated Manufacturing

    Position Summary

    We are seeking a results-driven Manufacturing Engineer to support process development, yield improvement, equipment qualification, and new product introductions within a regulated medical device environment. The ideal candidate will have strong DOE experience, Lean manufacturing expertise, and FDA-compliant manufacturing knowledge.

    Key Responsibilities

    • Develop and establish manufacturing processes based on product specifications and DFM principles
    • Run Design of Experiments (DOE) to improve yield and efficiency
    • Conduct equipment qualification and process validation (IQ/OQ/PQ)
    • Lead projects involving new production equipment, tooling, and process improvements
    • Drive cost reduction initiatives and understand Cost of Goods Sold (COGS)
    • Apply Lean Manufacturing and DMAIC tools to improve quality and throughput
    • Coordinate design, procurement, build, and debugging of tooling and test equipment
    • Partner cross-functionally with R&D, Quality, Finance, and Operations
    • Ensure compliance with FDA regulations, QMS, EMS, and OSHA standards
    • Mentor and coach technicians, operators, and trainers
    • Support divisional and company-wide quality initiatives

    Required Qualifications

    • Bachelor's Degree in Chemical, Mechanical, Industrial Engineering or related field
    • 5+ years of Manufacturing Engineering experience in medical device or regulated industry
    • Hands-on experience with DOE, process validation, and equipment qualification
    • Strong knowledge of FDA regulations, QMS, and Design Controls
    • Experience in matrixed, cross-functional environments
    • Strong analytical, problem-solving, and project management skills
    • Proficient in MS Office Suite

    Preferred Qualifications

    • Medical device manufacturing experience
    • Experience partnering closely with R&D
    • Delivery system/process yield improvement experience
    • Lean Six Sigma Green or Black Belt certification
    * This salary range is an estimation made by beBee
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