As Project Manager, you will provide the project coordination necessary to transfer proprietary disposable devices from the development phase to commercialization utilizing both internal and external resources while meeting the overall business requirements.
TO BE SUCCESSFUL IN THE ROLE YOU WILL NEED:
* Strong project management and leadership skills; ability to engage team in developing goals, executing plans and delivering results; ability to align resources with the business strategy to harmonize how they work and what they do.
* Strong verbal and written communication skills, with the ability to convey product concepts to subject matter experts and non-technical professionals.
* Strong business acumen to understand the organization's financial processes; ability to prepare, justify, and administer the program budget. Uses cost-benefit thinking to set priorities.
* PRIMARY RESPONSIBILITIES:
* Ensure the project activity is customer focused, results oriented and performance driven.
* Ensure that project implementation activities are carried out safely, utilizing materials meeting all necessary functional requirements and complying with all applicable internal and external regulatory, safety and environmental rules/requirements.
* Identify resources needed and finalize individual responsibilities in consultation with Management.
* Prepares detailed project schedules, including identification of major milestones, for overseeing, controlling, communicating and managing all activities required to complete the project.
* Monitor and control project costs through preparation regular project updates with Management and external customers.
* Verify actual or committed costs and identify cost variances which require further action to assure project costs are controlled.
* Establish/organize and maintain all interactions between internal groups and external vendors including conference calls, and meetings as needed.
* Coordinate and interface with external contacts including but not limited to: plastics companies, mold designers, mold manufacturers, material suppliers, packaging suppliers, regulatory, equipment suppliers, outside labs, customers, and consultants.
* Oversee and monitor the activities of consultants/contractors associated with the engineering/design and testing of device.
* Conduct regular status meetings, review progress reports and schedules, and work toward resolution of issues.
* Bachelor'sdegree inEngineering (MechanicalEngineeringpreferred) or related technical discipline, advanceddegree would bepreferred; certification in Project Management an asset.
* 7 - 10years of Project Management experience preferably in the medical devices or pharmaceutical industries, product development and/or process development. Solid technical experience with a proven track record of managing the development and commercialization of medical devices within a regulated environment.
* Experience in multiple and simultaneous project management.
* Experience in managing and working in a multidisciplinary team.
* Knowledge of quality and regulatory requirements guiding medical device development, plus experience dealing with regulatory agencies or outside professional groups (e.g., FDA, ISO).