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Engineering Jobs

Validation Engineer

Katalyst Healthcares & Life Sciences

  • Boston, MA
  • 8 days ago

    Highlights

    The role involves planning and executing V&V activities, developing and executing validation protocols, supporting design verification, and ensuring compliance with FDA, ISO 13485, and internal quality system requirements. Job Summary: We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products.

    Numbers & Facts

    LocationBoston, MA

    Description

    Job Summary:
    • We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products.
    • The role involves planning and executing V&V activities, developing and executing validation protocols, supporting design verification, and ensuring compliance with FDA, ISO 13485, and internal quality system requirements.
    • Experience with infusion pump systems or similar electromechanical medical devices is preferred.
    Roles & Responsibilities:
    • Plan and execute system-level Verification & Validation (V&V) activities for medical device products.
    • Develop, review, and execute validation protocols, test plans, and test reports.
    • Perform validation testing, document results, investigate failures, and support issue resolution.
    • Ensure validation activities comply with applicable quality standards, regulatory requirements, and internal procedures.
    • Collaborate with cross-functional teams including R&D, Quality, Regulatory, Manufacturing, and Systems Engineering.
    • Support design verification, risk management, and product validation efforts.
    • Maintain accurate documentation in accordance with FDA, ISO 13485, and company quality system requirements.
    • Participate in design reviews and provide technical input related to system validation.
    Education & Experience:
    • Bachelor's degree in Engineering or a related technical discipline.
    • Minimum 10 years of Validation Engineering experience.
    • Strong experience in the Medical Device industry, preferably with infusion pumps or similar electromechanical medical devices.
    • Hands-on experience with System-Level Verification & Validation (V&V).
    • Proven experience executing validation protocols, documenting results, and resolving validation issues.
    • Strong understanding of design controls, validation processes, and quality systems.
    • Excellent communication and documentation skills.
    • Preferred: Experience working with FDA-regulated medical devices.
    • Preferred: Knowledge of ISO 13485, 21 CFR Part 820, IEC 60601, and related medical device standards.
    • Preferred: Previous experience with client or other leading medical device manufacturers.

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