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Test Method Validation

Katalyst Healthcares & Life Sciences

  • Santa Clarita, CA
  • 30+ days ago

    Highlights

    The ideal candidate will have strong experience in Design Controls, Design Verification & Validation (DV&V), Risk Management, and Quality Engineering within a regulated medical device environment. Review build protocols, build reports, Device History Records (DHR), and configuration changes to assess impact on verification activities.

    Numbers & Facts

    LocationSanta Clarita, CA

    Description

    Job Summary:
    • We are seeking an Engineer to support product development and design verification activities for medical device programs.
    • The ideal candidate will have strong experience in Design Controls, Design Verification & Validation (DV&V), Risk Management, and Quality Engineering within a regulated medical device environment.
    Roles & Responsibilities:
    • Review and support Design Verification deliverables, including protocols, reports, and summary reports.
    • Review and support Test Method Validation activities and test fixture design qualification.
    • Analyze regression impacts and ensure changes are properly assessed and justified.
    • Support Installation Qualification (IQ) activities for non-product software and test equipment.
    • Participate in risk management activities, including review and assessment of dFMEA for product subsystems.
    • Collaborate with cross-functional teams on defect tracking, issue resolution, test execution, and quality improvement initiatives.
    • Review build protocols, build reports, Device History Records (DHR), and configuration changes to assess impact on verification activities.
    • Review engineering design changes, including mechanical and electrical drawings.
    • Support the development and review of inspection plans for components and sub-assemblies.
    • Ensure compliance with Design Control processes and applicable quality system requirements.
    • Provide quality engineering support throughout the product development lifecycle.
    Education & Experience:
    • Bachelor's degree in Engineering or a related technical discipline.
    • 5+ years of experience in Quality Engineering, Design Assurance, or Product Development Quality within the Medical Device industry.
    • Strong knowledge of Design Controls, Design Verification & Validation (DV&V), and Risk Management processes.
    • Experience reviewing Design Verification protocols, reports, and validation documentation.
    • Hands-on experience with dFMEA, defect management, and root cause analysis.
    • Familiarity with Device History Records (DHR), inspection plans, and configuration management.
    • Experience reviewing mechanical and electrical engineering documentation.
    • Knowledge of FDA Quality System Regulations, ISO 13485, and medical device development processes.
    • Strong analytical, documentation, communication, and problem-solving skills.
    • Experience with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
    • Knowledge of CAPA, change control, and product lifecycle management processes.
    • Experience supporting complex medical device product development programs.

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