Sr Manager, Systems Engineering (Life Sciences) – Canon U.S.A., Inc. – Rockville, MD

Canon U.S. Life Sciences, Inc., a subsidiary of Canon U.S.A., Inc., is dedicated to extending innovative Canon core technologies into the burgeoning life sciences field — and to the introduction and marketing of vital, new-platform products in the critical area of molecular diagnostics.

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 and follow us on Twitter @CanonUSA. For media inquiries, please contact .

† 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:

  • Oversees and directs the activities of engineering teams engaged in the analysis, design, programming, debugging and modification of modules and systems for commercial IVD diagnostic instrumentation.
  • Plans, directs, and implements the Canon BioMemdical Inc. (CBMI) systems engineering functions, which may include any of the following activities: reliability standards pertaining to the materials and techniques used in design and production, activities of a mechanical systems and equipment function, activities of a research or technical design function responsible for designing, developing, modifying and evaluating electronic parts, components or integrated circuitry for electronic equipment and other hardware systems.
  • Analyzes and investigates applications engineering tasks and prepares design specifications, analysis, and recommendations.
  • Conducts feasibility studies of the design to determine if capable of functioning as intended.
  • Monitors documentation maintenance throughout all phases of development and design transfer.
  • Organizes the coordination of activities with outside suppliers and consultants and other Canon business entities to ensure timely delivery.
  • Interacts with users to define application requirements and/or necessary modifications.
  • Takes direct responsibility for design, testing, and documentation of prototype modules and instrumentation system under Design Control.
  • Reviews alternative technology IP as it relates to the design process. Keep abreast of relevant and new technologies in the diagnostics field.
  • Performs root cause analysis and provides a risk assessment of designs in consideration of the clinical and medical use environments for molecular diagnostic instruments.
  • Develops and implements metrics/actions that assure effective and efficient project processes.
  • Defines and manages the scope of response/urgency and able to manage tasks effectively with functional leads to obtain resources and other support whenever needed.
  • Takes direct responsibility for instrument reliability and manufacturability.
  • Leads teams to identify and deliver opportunities for performance, reliability, and quality improvements.
  • Provides consultation on complex projects.
  • Reports progress regularly to Sr. Management.
  • Education: Minimum BS in Electrical Engineering, Mechanical Engineering, Systems Engineering, Biomedical Engineering, or related engineering discipline is required; MS in Engineering strongly preferred; (MBA not an equivalent substitute for Degree in Engineering)
  • Experience: Minimum 10+ years experience in complex systems development (Harware and Software) is required, with 7+ years in molecular diagnostic and/or Medical Device product development, and 5+ years experience in a team leadership, supervisory or management role is required.
  • Specific accomplishments launching complex products combining electronics, embedded software/firmware, GUI, and consumable/disposable components is required. Successful product launch experience resulting in significant incremental revenue is required.
  • Knowledge of In Vitro Diagnostic (IVD) instruments and design of electromechanical systems is required.
  • Strong Knowledge of CAD systems and Lab View systems is required.
  • Experience with CSV, SVN, or other software versioning system is required.

Experience with optics, PCR and/or microfluidics is preferred.

  • Knowledge of various manufacturing processes including injection molding, sheet metal, castings, machining and/or electronics assembly and testing is required.

Experience with vendor management (OEM, CMO, etc.) and defining inputs/specifications for outsourced vendors is required.

  • Experience dealing with problem reporting, problem escalation, design control (FDA 21 CFR. Part 820 and ISO 9001), risk assessments, corrective and preventative action, change control, product support.
  • Excellent oral and written communication skills with the ability to communicate clearly to others in different functions at various levels is required.
  • Ability to work effectively in cross-functional teams consisting of engineering, assay development, manufacturing, QA/RA, and marketing is required.

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Canon U.S.A., Inc., headquartered in Melville, New York, is a leading provider of consumer, business-to-business, and industrial digital…

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