Design Quality Engineer - Auburndale - Infosoft, Inc.

    Infosoft, Inc.
    Infosoft, Inc. Auburndale

    1 day ago

    $90,000 - $155,000 (USD) per year * Upper Management / Consulting
    Description

    Job Title: Design Quality Engineer (Medical Device)-(USC/GC Only)

    Pay Rate: $65 to $70/Hr

    Duration: 12 months

    Location: Newton, MA

    We are looking for a Design Quality Engineer (Medical Device) to join our Endovascular Robotics development group.

    New Product Development :

    • Act as a Quality subject matter expert supporting the development of sterile, single-use medical devices, with ownership of packaging, sterile barrier systems, sterilization, and biocompatibility considerations to ensure compliance with applicable standards and internal quality system requirements.
    • Support risk management activities in accordance with ISO 14971, including identification, analysis, mitigation, and documentation of risks throughout the design lifecycle within the Risk Management File.
    • Support the development of Use, Design, and Process FMEAs to systematically identify and address potential failure modes and ensure appropriate risk controls are implemented.
    • Support design verification and validation activities, including development, review, and approval of test plans, protocols, and reports, with a focus on compliance testing for biocompatible, sterile, single-use consumable products (e.g., ISO 10993, IEC , packaging and sterilization-related testing).
    • Support the development and maintenance of the Usability Engineering File in accordance with IEC 62366 and applicable regulatory requirements.
    • Support supplier qualification and process validation activities, including review of supplier documentation and quality outputs.
    • Support test and inspection equipment evaluation, method development, and qualification activities as required.
    • Support manufacturing transfer activities, including creation and review of DMR/DHR documentation and execution or review of validation protocols (IQ, OQ, PQ).
    • Develop, review, and maintain work instructions, manufacturing procedures, and inspection documentation to ensure alignment with validated processes and design requirements.

    Sustaining Activities :

    • Support the collection, analysis, and trending of quality and performance metrics to identify opportunities for improvement.
    • Propose, lead, and support Corrective and Preventive Actions (CAPAs) to address systemic issues and ensure effective resolution.
    • Lead and/or participate in product complaint investigations, including root cause analysis and documentation of findings.
    • Support the disposition of nonconforming material, including collaboration with cross-functional teams to determine appropriate actions.

    Requirements:

    • Bachelor's degree in Engineering, Biomedical Engineering, or Life Sciences.
    • 5–7 years of experience as a Quality Engineer or Design Quality Engineer in the medical device industry, supporting development and sustaining activities for sterile, single-use consumables and packaging.
    • Hands-on experience with ISO , ISO , and ISO 11135 preferred.
    • Working knowledge of QMSR, ISO 13485, ISO 14971, IEC 62366, and MDD/MDR requirements.
    • Experience with applied statistics, including the use of Minitab or equivalent statistical software.
    • Demonstrated experience in CAPA, nonconformance management, and complaint investigations.
    • Experience supporting De Novo and/or PMA submissions is preferred.
    • Strong verbal and written communication skills, with the ability to author clear, concise, and technically sound procedures, protocols, analyses, and reports, and to collaborate effectively with internal and external stakeholders.
    * This salary range is an estimation made by beBee
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