Medical Device Manufacturing Engineer - Seattle - Radiant Dev

    Radiant Dev
    Radiant Dev Seattle

    1 week ago

    Description

    Overview

    We are seeking a hands-on quality assurance engineer with strong manufacturing, root-cause analysis, and quality systems experience. This hybrid Quality/Manufacturing role owns key elements of the Quality Management System (QMS), including Nonconformance Management, Equipment Qualification/Calibration, Incoming and In-Process Inspection, and Supplier Quality, while contributing to improving product quality, cost, and manufacturability.

    Responsibilities

    • Lead investigations and manage dispositions for all manufacturing nonconformances.
    • Review, optimize, and validate manufacturing processes for quality and regulatory compliance.
    • Own tooling and equipment qualification and calibration.
    • Manage supplier quality, including evaluations, audits, and SCARs.
    • Drive internal CAPAs tied to manufacturing issues.
    • Track production data, identify trends, and drive continuous improvement efforts.
    • Train and support the team on QMS processes, GMP, and process controls.
    • Maintain and improve manufacturing documentation, inspection procedures, and Device History Records.

    Required Qualifications

    • Bachelor's degree in Manufacturing, Mechanical, Biomedical, or Industrial Engineering; or 8+ years of relevant experience.
    • 3+ years in a regulated environment (medical devices preferred).
    • Clear, concise technical writing skills.
    • Working knowledge of QMS elements such as CAPA, Training, Nonconformance, and Change Control.
    • Familiarity with ISO 13485.
    • Comfortable supporting internal and external audits.

    Skills That Will Make You Successful

    • Practical experience in manufacturing and quality engineering.
    • Detail-oriented mindset with a focus on mistake-proofing.
    • Solid engineering fundamentals: materials, manufacturing, test methods, and root cause analysis.
    • Clear communicator with both technical and nontechnical stakeholders.
    • Collaborative team player and proactive problem solver.

    The company provides a comprehensive benefits package, including medical insurance, dental reimbursement, 15 days of paid time off (PTO) plus federal holidays, and a 401(k) plan with both pre-tax and Roth options.


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