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Medical Device Catheter Development Engineer

Company: Canon U.S.A., Inc.
Location: Cambridge
Posted on: November 23, 2022

Job Description:

US-MA-Cambridge Canon U.S.A., Inc.Requisition ID: 28693Category: Medical DevicePosition Type: Full-TimeOverviewCanon's Healthcare Optics Research Laboratory is currently seeking an experienced Medical Device Catheter Development Engineer (Engineer) to design robotic catheters, from initial concept to commercialization, in collaboration with world leading medical institutions.Healthcare Optics Research Laboratory is located in Cambridge, MA and will be the home of skilled employees dedicated to developing biomedical optical imaging and medical robotics technologies with the ultimate goal of bringing to market medical devices for a variety of applications.This position is full time and offers a hybrid work schedule requiring you to be in the office three days per week and an option to work from home two days per week. Note that work schedules and office reporting requirements may change from time to time based on business needs. Responsibilities- Responsible for design and builds of innovative, robust and reliable minimally-invasive robotic catheters from early concept to release into production- Understand and conform to requirements of FDA regulations and the Canon Quality System- Translate clinical needs into detailed technical specifications and create the appropriate documentation- Research and integrate new technologies and materials by utilizing technical knowledge and understanding of complex ideas, concepts, and theories- Produce prototypes and provide process improvements for the catheter and other disposable components- Provide oversight for a catheter assembler to ensure quality assurance and manage inventory stock- Collaborate with vendors and external partners on sourcing of catheter materials and components- Develop requirements and provide guidance to catheter contract manufacturers for catheter development- Contribute to risk analysis, including dFMEA and pFMEA, to assure product safety and reliability- Conduct feasibility and reliability testing for robotic catheters and author test reports- Lead activities for designing, building, improving and documenting custom test equipment, fixtures, and methods- Contribute to collaborative environment with a cross-functional team including R&D, Quality, Clinical, Regulatory, Operations- Provide documentation of inventions for patent applications; review alternative technology IP as it relates to the design processResults Expected:- Produce innovative product and/or component designs for prototype devices that consider user needs, feasibility of design, and business constraints- Generate functional prototype units to be used for engineering evaluations- Produce documentation of design requirements, risk analysis, experiments/tests results and drawings- Submit memo of inventions for preparation of patent applications QualificationsPlease note: We comply with all applicable federal, state and local laws, regulations, orders and mandates, including those we may be required to follow as a federal government contractor/subcontractor.- Bachelor's degree or higher in Engineering (Materials, Mechanical, Plastics, or Biomedical)- 3-5 years of relevant experience in design of medical devices and product development in a FDA regulated industry- Catheter design with modeling and analysis using SolidWorks or similar experience is required- Experience working in a fast-paced, rapid prototype design environment- Experience in new product design and development including conceptual design efforts, making appropriate modifications throughout the design process- Experience working with materials such as polymers, metals, and ceramics- Excellent knowledge of catheter manufacturing process and equipment- Experience working with consultants, outside partners, and suppliers- Strong verbal and written communication skills with the ability to communicate clearly to others in different functions and at various levelsThe company will not pursue or support visa sponsorship for this position. Company OverviewAbout our Company - 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 $30.4 billion in global revenue, its parent company, Canon Inc. (NYSE:CAJ), ranks third overall in U.S. patents granted in 2020--- and is one of Fortune Magazine's World's Most Admired Companies in 2020. Canon U.S.A. is dedicated to its Kyosei philosophy of social and environmental responsibility. 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. ---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 U.S.A., Inc. offers a competitive compensation package including medical, dental, vision, 401(k) Savings Plan, discretionary profit sharing, discretionary success sharing, educational assistance, recognition programs, vacation, and much more. A more comprehensive list of what we have to offer is available at We comply with all applicable federal, state and local laws, regulations, orders and mandates, including those we may be required to follow as a federal government contractor/subcontractor. We are an EEO/AA employer. Minority/Female/Individuals with Disabilities/Protected Veterans.If you are not reviewing this job posting on our Careers' site, we cannot guarantee the validity of this posting. For a list of our current postings, please visit us at Posting Tags#PM19 #LI-AV1 #CUSA #LI-HYBRIDPI196605207

Keywords: Canon U.S.A., Inc., Cambridge , Medical Device Catheter Development Engineer, Engineering , Cambridge, Massachusetts

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