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Medical Device Project Management Specialist

Medical Device Project Management Specialist

Overview

Canon USA’s Healthcare Optics Research Lab is collaborating with world-class hospitals in the Boston area to turn cutting-edge medical research into usable, meaningful products. The Medical Device Project Management Specialist (Specialist, Projects HORL) will lead product development programs or projects for the Lab. This includes creating and maintaining the project schedules, leading the implementation processes for planning and execution of all product development activities and deliverables to meet business objectives and to comply with regulatory requirements for medical devices.


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Responsibilities

- Responsible for project planning including defining project scope, project milestones, and developing tasks with estimates; author project plans that meets business objectives and complies with the quality management system
- Responsible for scheduling regular project status update meetings and reviews with a cross-functional project team; ensures deliverable are completed and documented to meet the quality requirements following design control procedures
- Responsible for identifying project risks, both technical and managerial, and devise 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 stakeholders

Qualifications

- Education required: Minimum Bachelor degree in engineering, life science or related discipline
- 3-5 years of project management experience with medical device 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
The company will not pursue or support visa sponsorship for this position.

Company Overview

About 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 $36 billion in global revenue, its parent company, Canon Inc. (NYSE:CAJ), ranks third overall in U.S. patents granted in 2018† and is one of Fortune Magazine's World's Most Admired Companies in 2019. Canon U.S.A. is committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based service and support for all of the products it distributes in the United States. 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.

We are an EEO/AA employer. Minority/Female/Individuals with Disabilities/Protected Veterans.

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