• Sr. Engineer, Catheter and Clinical Development

    Job Locations US-MA-Cambridge
    Job ID
    8123
    Experience (Years)
    8
    Category
    Engineering
  • 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 development phase organization that will commercialize several image guided therapy products in the near future. We have an established partnership with world class hospitals in the Boston area (Partners Healthcare) to turn cutting-edge medical research into usable, meaningful products. With the recent acquisition and integration of Toshiba Medical Systems, now known as Canon Medical Systems, we operate as a “start-up” within a market leading medical imaging group under the global Canon enterprise.
     
    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

    Canon Healthcare Optics Research Laboratory is currently seeking an experienced, Senior Clinical R&D Engineer, to develop medical optical imaging catheters from prototypes through preclinical and clinical phase, in close collaboration with world’s leading medical institutions and contract manufacturers.
     
    #CUSA #LI-CM1

    Responsibilities

    - Lead catheter design verification planning and execution through contract manufacturer.
    - Provide guidance to contract manufacturer for test method development and validation.
    - Lead risk assessment activities to assure catheter safety and reliability.
    - Design and conduct bench, ex-vivo and in-vivo preclinical verification and validation tests. 
    - Design and develop test methods for bench, ex-vivo and in-vivo preclinical tests and create reports for regulatory submission.
    - Support clinical development efforts from site engagement, contractual agreement, investigator training, and data management, and interface with CROs/ clinical associates. 
    - Provide documentation of inventions for patent applications and review alternative technology IP as it relates to the design process.
    - Ensure Good Manufacturing Practices, Quality System Regulations and Medical Device Design Controls are followed.
    - May supervise engineers and technicians assigned to projects. 

    Qualifications

    - Bachelor’s degree or higher in Engineering (Materials, Mechanical, Plastics, or Biomedical) and 8-10 years of relevant experience in design of medical devices and product development.
    - Expert materials knowledge in polymer, metals, and ceramics.
    - Expert knowledge in catheter design and manufacturing processes and equipment. 
    - Knowledge in statistics and analytical methods such as SPC, SQC, and DOE.
    - Proficient with rapid prototyping techniques.
    - Proficient in modeling and analysis of mechanical systems using SolidWorks or similar.
    - Experience working with consultants, outside partners, and suppliers.
    - Excellent verbal and written communication skills with the ability to communicate clearly to others in different functions and at various levels. 

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