• Senior Manager, Systems Engineering

    Job Locations US-MA-Cambridge
    Job ID
    7528
    Experience (Years)
    8
    Category
    Medical Device
  • 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

    The Senior Manager – Systems Engineering at Canon USA Healthcare Optics Research Lab will be responsible for leading the systems engineering team for design, implementation and verification of innovative medical imaging systems in collaboration with world’s leading medical institutions.  This is a highly visible role where you will join the project leadership team having an opportunity to directly interact with key stakeholders including KOLs and world-class researchers.  We are seeking a highly-motivated, execution-focused leader with the ability to define roles and activities necessary for a successful product commercialization.
     
    #CUSA #LI-CM1

    Responsibilities

    - Build and establish a high-performance system engineering team by developing, mentoring and coaching each engineer as appropriate. Inspire and motivate the team members to achieve individual and project goals.
    - Analyze, evaluate and plan approaches on complex technical challenges. Demonstrate strong system engineering knowledge and expertise within FDA regulated industries, good judgment and timely decision-making by providing leadership to project team members and commits resources to execute specific project tasks. 
    - Working from an established mastery of 21 CFR Part 820, lead the team through all Design Control phases.
    - Coordinate project work with functional and external stakeholders with a solid understanding of overall project goals, schedule, and deliverables. Demonstrate strong and clear accountability for project success.
    - Create and effectively manage budget and resource allocation within the organization.
    - Interface and collaborate with group companies including software engineering and manufacturing.
    - Build and maintain relationships with key vendors and assist with technical aspects of vendor negotiations.
    - Ensure compliance with Canon quality policies, procedures, and practices.
    - Work effectively in cross-functional teams consisting of Clinical, Design & Usability, Marketing, R&D, Quality, and Regulatory.
    - Provide leadership and guidance for novel inventions for patent applications.
    - Report progress regularly to Upper Management.

    Qualifications

    - Bachelor’s Degree in Engineering, Computer Science or similar with 5-8 years of product development experience of complex systems. At least 3-5 years of management experience where software engineering is a major component. 
    - Strong technical knowledge of software engineering, both tools and processes, is required.
    - Experience in project management of medical devices under Design Control (21 CFR Part 820) and ISO 14971 is strongly preferred.
    - Experience leading teams with external design, development and manufacturing partners.
    - Must be comfortable working in a multi-functional matrixed organization under the Quality System.
    - Experience in intellectual property development is a plus.
    - Excellent oral and written communication skills with the ability to communicate clearly to upper management and other stakeholders in different functions at various levels.
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