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Medical Device Senior Project Management Specialist

Company: Canon U.S.A., Inc.
Location: Cambridge
Posted on: November 22, 2022

Job Description:

US-MA-Cambridge Canon U.S.A., Inc.Requisition ID: 28713Category: Medical DevicePosition Type: Full-TimeOverviewCanon USA's Healthcare Optics Research Lab collaborates with world-class hospitals in the Boston area to turn cutting-edge medical research into usable, meaningful products. The Medical Device Senior Project Management Specialist will lead and manage product development programs or projects for the Lab. This includes creating and maintaining the project schedules, and leading the implementation processes for planning and executing all product development activities and deliverables to meet business objectives while complying with regulatory requirements for medical devices.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 project planning including defining project scope, project milestones, and developing tasks with estimates; author project plans that meet business objectives and comply with the quality management system- Responsible for scheduling regular project status update meetings and reviews with a cross-functional project team; ensures deliverables are completed and documented to meet the quality requirements following design control procedures- Responsible for identifying project risks, both technical and managerial, and devising appropriate risk management plans; regularly assess and report project risks to management- Responsible for project execution of product development projects within FDA-regulated industries while adhering to scope, schedule, and budget requirements- Apply best practices in initiating, planning, executing, controlling, and closing processes of projects and ensure consistent practices throughout all phases of the project life cycle- Use defined project management practices and procedures to identify root-cause of project issues and develop a plan to resolve problems of moderate scope and complexity- Facilitate cooperation of a cross-functional team consisting of R&D, Usability, Clinical, Quality, Regulatory, Marketing, Operations, and external stakeholders- Responsible for communicating project key metrics and updates on project status (timelines, resources, and delays) to both the project team as well as management and key project stakeholdersResults Expected:- Development and maintenance of project charters and project plans- Creation and maintenance of WBS (Work Breakdown Structure)- Creation and maintenance of project risks and project issues- Creation of project-level progress reports and meeting minutes- Tracking key project milestones; Reporting of Key Performance Indicators 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.- Minimum Bachelor's degree in engineering, life science, or related discipline required- 5+ years of project management experience within the medical device industry or related is required- Demonstrated experience managing medical device development projects having a strong understanding of Quality Management Systems including ISO 13485 and 21 CFR Part 820 throughout the product development lifecycle- Proficient with MS Project or similar Project Management tools- Comfortable with complexity, ambiguity, and change- Ability to balance competing priorities- Ability to communicate with impact and establish credibility necessary to influence at all organizational levels- Fluent with MS Office tools such as Excel, Word, and PowerPoint- Experience with product development tools such as JIRA, JAMA, MasterControl- Solid understanding of industry standards and best practices in project management- Solid oral and written communication skills with the ability to communicate clearly to other stakeholders in different functions at various levels- Strong interpersonal skills with the ability to function effectively and tactfully with multiple departments and personnel, able to gain consensus and commitment- Project Management Professional (PMP) certification a plusThe 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 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 .

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Keywords: Canon U.S.A., Inc., Cambridge , Medical Device Senior Project Management Specialist, Healthcare , Cambridge, Massachusetts

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