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 Senior Project Management Specialist (Sr. Specialist, HORL Projects) will lead and manage product development programs or projects for the Lab. This includes managing the project schedule and implementation process for planning and execution of all product development activities and deliverables in compliance with FDA's Design Control requirements for medical devices and in alignment with Canon's New Product Development (NPD) business phase-gate process.
- Responsible to take input from a cross-functional project teams to develop and maintain a detailed project schedule and execute a high quality, integrated cross-functional plan for projects
- Manage the planning and execution of product development projects within FDA regulated industries while adhering to budget, scope and schedule requirements
- Applies best practices in the development, initiation, planning, execution, control and closing of projects and ensures consistent practices throughout all phases of the project life cycle
- Leads activities such as scheduling project status update meetings with project teams and gathers information and prepares meeting minutes and schedule updates
- Use defined project management practices and procedures to solve problems of moderate scope and complexity
- Interact effectively and appropriately with a cross-functional team in R&D, Clinical, Quality, Regulatory, Marketing, Operations and external stakeholders
- Serves as in-house project consultant for R&D projects
- Effectively communicate project key data and updates on project status (timelines, resources, and delays) status to management and key project stakeholders
- Education Required: Minimum Bachelors' degree in a scientific or engineering discipline
- At least 5 years of direct Project Management in Medical Device or related experience is required. Demonstrated experience managing schedules for complex, cross-functional projects
- 5+ years of engineering or related industry experience is required. Medical Device development is preferred
- Demonstrated experience managing medical device development projects having a strong understanding ofQuality Management Systemsincluding ISO 13485 and 21 CFR Part 820 throughout the product development lifecycle
- Strong experience with MS Project, Excel, Word, and Visio
- Experience usingALM/PLM tools and other project management tools such as JIRA
- PMP Certification
- Excellent 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 proven ability to function effectively and tactfully with multiple departments and personnel, able to gain consensus and commitment
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 firstname.lastname@example.org .
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