• Principal Software Quality Engineer

    Job Locations US-MA-Cambridge
    Job ID
    Experience (Years)
    Quality Systems
  • Company Overview

    The Canon Healthcare Optics Research Laboratory is a division of Canon U.S.A., Inc.
    Canon Healthcare Optics Research Lab (HORL) is a young organization that is gaining momentum. We’re partnering with world class hospitals in the Boston area to turn cutting-edge medical research into usable, meaningful products.
    Canon U.S.A., Inc., is a leading provider of consumer, business-to-business, and industrial digital imaging solutions to the United States and to Latin America and the Caribbean (excluding Mexico) markets. With approximately $31 billion in global revenue, its parent company, Canon Inc. (NYSE:CAJ), ranks third overall in U.S. patents granted in 2015† and is one of Fortune Magazine's World's Most Admired Companies in 2016. Canon U.S.A. is committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based consumer service and support for all of the products it distributes. Canon U.S.A. is dedicated to its Kyosei philosophy of social and environmental responsibility. In 2014, the Canon Americas Headquarters secured LEED® Gold certification, a recognition for the design, construction, operations and maintenance of high-performance green buildings. To keep apprised of the latest news from Canon U.S.A., sign up for the Company's RSS news feed by visiting www.usa.canon.com/rss and follow us on Twitter @CanonUSA. For media inquiries, please contact pr@cusa.canon.com.

    † Based on weekly patent counts issued by United States Patent and Trademark Office.

    All referenced product names, and other marks, are trademarks of their respective owners.
    Canon is proud to be an equal opportunity employer. Minority/Female/Individuals with Disabilities/Protected Veterans. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identification, national origin, disability, genetic information or protected veteran status, or any other characteristic protected by law. To read more about employment discrimination protections under federal law, please visit this site: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf

    Position Overview

    Be a part of the Quality team at our Healthcare Optics Research Laboratory and drive Software Quality for the development of unique biomedical devices in collaboration with world’s leading medical institutions.  We are seeking an experienced Principal Software Quality Engineer who can lead Software Quality program and drive compliance.


    - Lead the development and implementation of the Software Lifecycle Development process. Manage the consultants developing the software procedures, work instructions and templates required to conduct and document software in compliance with FDA regulations and guidances, ISO 13485 and IEC 62304. Train and mentor software engineers on compliance to these documents. Drive product and process improvements.
    - Manage the Software Lifecycle Development Process. Ensure that all projects are following the process in a timely manner and compliant manner. Develop and report the needed metrics to ensure that projects are meeting milestones and are compliant and management is aware of any risks.
    - Facilitate and participate in the development of software requirements for one or more projects along with the software engineers assigned to the project team. Ensure that the software requirements are aligned with the project’s Design Input specifications. 
    - Drive and facilitate software risk assessments and failure analyses for one or more projects in compliance with IEC 62304 and ISO 14971. 
    - Write software validation protocols. Mentor engineers and technicians in writing verification protocols and test scripts. Identify and manage resources for conducting testing. 
    - Perform ad hoq software testing to identify software issues early. Determine which software elements require code review and perform code review.
    - Develop and execute protocols for validating off-the-shelf software, systems or processes for Quality Management System processes. 
    - Assist in the selection of software tools including software development tools, configuration management tools, and issue tracking tools. Work with vendors and software team to assess the candidate tools’ technical capability, usability, vendor support; and implementation resource requirements. Validate and document these software tools. 
    - Ensure that Software configuration management is properly conducted and that software bugs are properly tracked and addressed. Evaluate bugs to identify priority. Review and provide Quality approval of the resolution of these bugs.
    - May write the software sections of FDA 510(k) or de Novo submissions for clearance of new products.


    - Education: BS or higher degree in computer science, engineering, or similar.
    - Experience: 10 years minimum software engineering or software quality experience in Medical Devices. Experience in writing software procedures and validating software tools. 
    - In-depth understanding of Medical Device software development regulatory requirements, best practices and technical standards including 21 CFR 820, ISO 13485, and IEC 62304.
    - Experience in managing Software Lifecycle Development processes. Experience in leading software verification and validation activities, developing software requirements documents, and conducting software risk management activities. Ability to read code and perform code reviews. 
    - Skills: Proficient in Microsoft Office. 
    - Must be a team player and possess strong oral and written communication skills.
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