Analogic

  • Design Assurance Engineer

    Job Locations US-MA-Peabody
    Job Post Information* : Posted Date 3 months ago(8/31/2018 3:54 PM)
    ID
    2018-1564
    # of Openings
    1
    Category
    Quality
    Type
    Regular Full-Time
  • Overview

    Analogic provides leading-edge healthcare and security technology solutions to advance the practice of medicine and save lives. We are recognized around the world for advanced imaging systems and technology that enable computed tomography (CT), ultrasound, digital mammography, and magnetic resonance imaging (MRI), as well as automated threat detection for aviation security. For over 40 years we’ve enabled customers to thrive, improving the health and ensuring the safety of people around the world. Analogic is headquartered north of Boston in Peabody, Massachusetts.

     

    POSITION SUMMARY:

     

    Represents the Quality, Compliance and Reliability teams working within guidelines of the Quality Management System (QMS) supporting the overall Design Assurance process for all new product development and sustaining engineering projects. Ensures design control outputs meet all Customer, Regulatory, and QMS requirements.

    Responsibilities

    • Partners with R&D, Marketing and Program Management as a core team member on new and sustaining projects to determine and define design inputs, design outputs, and design input/output relationships for traceability and gap analysis of project deliverables while maintaining independent project oversight.
    • Develops and implements new and improved pre-market Design Assurance techniques and processes.
    • Determines and documents all risks associated with projects (Hazard Analysis, DFMEA, PFMEA, etc.) by creating and updating project risk analyses reports and risk management files.
    • Develops and implements effective controls and evaluations to support the qualification of projects to meet or exceed all internal and external requirements ensuring auditable documentation trails.
    • May generate or assist with generation of test protocols, manage test execution, investigate test issues, analyze data, and create reports for design and/or process verification and validation testing.
    • Supports Quality, Compliance and Reliability personal with creating regulatory submissions, responding to submission questions, and assisting with overall regulatory compliance maintenance.
    • Participates in post-market surveillance activities such as customer complaints, reportable events, and trend analysis for possible design improvement and/or lessons learned as input to future projects.
    • May lead or participate in Corrective and Preventive Actions (CAPA) and QMS continuous improvement projects as they relate to Design Assurance.
    • Ensures creation and maintenance of Design History Files (DHFs) throughout all projects stages and supports transfer of product development projects to production.
    • Provides design control guidance and training to less experienced personnel and provides technical support to engineering staff by interpreting industry standards, directives, and requirements.

    Qualifications

    EDUCATION:       

      
    BSEE, BSME, or equivalent advanced technical degree preferred.                   
    ASQ Certified Quality Engineer or equivalent industry certification a plus.

    EXPERIENCE:

    5+ years related experience with electromechanical products desired.

    2+ years additional related experience in the medical device industry preferred.
    Risk management, reliability, verification, validation and design review experience desired.

     

    COMPETENCIES:

     

    • Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 9001, IEC 60601, FIT predictions and/or MIL HDBK 217 methods, ISO 14971 and ISO 12100 Risk Management, FDA-QSRs, Health Canada, EU MDD and MDR, Low Voltage, EMC and Machinery Directives, Clinical Studies, Medical Device Usability/Human Factors and general Global Quality, Compliance and Regulatory requirements.
    • Ability to organize and prioritize workflow to meet established time frames and schedules.
    • Must be able to work both independently and in support of cross-functional teams.
    • Ability to generate or update procedures that support a corporate-level QMS.
    • Excellent interpersonal, verbal, and written communication skills.
    • Proficiency with Word, Excel, PowerPoint, Access, Agile, and SAP.
    • Up to 20% local travel required between Peabody and Canton facilities.

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