• Sr. Quality Engineer / Sr. Software Quality Engineer - Biomedical Devices

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

    Canon’s Healthcare Optics Research Lab, a division of Canon U.S.A., Inc., was established in 2013 and has collaborative research agreements with Massachusetts General Hospital and Brigham & Women’s Hospital to develop biomedical optical imaging and medical robotics technologies, with the ultimate goal of bringing medical devices to market.  These devices will be used for a variety of applications, including Image Guided Therapy, Miniature Endoscopic Imaging, and Functional Imaging.
    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 markets. With approximately $29 billion in global revenue, its parent company, Canon Inc. (NYSE:CAJ), ranks third overall in U.S. patents granted in 2016† 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.
    We are an EEO/AA employer. Minority/Female/Individuals with Disabilities/Protected Veterans.

    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 the world’s leading medical institutions.  We are seeking an experienced Senior Software Quality Engineer who can lead Software Quality program and drive compliance.


    - Collaborate in the development and maintenance of 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.
    - 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.
    - Mentor/collaborate with software engineers on writing software test plans and verification and validation protocols as well as test scripts.
    - 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. Drive the documentation and validation of these tools, including writing protocols.
    - Ensure that Software configuration management is properly conducted and that software bugs are properly tracked and addressed
    - Drive product and process improvements.


    - Education: BS or higher degree in computer science, engineering, or similar.
    - Experience: 5 years minimum software engineering or software quality experience in Medical Devices. Experience in writing software procedures and validating software tools is a plus.
    - 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 conducting software verification and validation, developing software requirements documents, and conducting software risk management activities. Ability to read code is a plus.
    - Skills: Proficient in Microsoft Office.
    - Must be a team player and possess strong oral and written communication skills.
    - Applicants are encouraged to providing writing samples that demonstrate their writing capabilities.
    If you are not reviewing this job posting on our Careers’ site https://www.usa.canon.com/internet/portal/us/home/about/careers, we cannot guarantee the validity of this posting. For a list of our current postings, please visit us at https://www.usa.canon.com/internet/portal/us/home/about/careers.


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