Seeking a Sr. Program Manager R&D with 7+ years medical device, extensive new product development & project management experience . PMP certification preferred.
•Drive the development of new medical device development programs through project completion within timeline, quality and budgetary limits
•Lead and integrate cross-functional teams and manage deliverables in a matrix organization
•Lead, manage and direct the development and execution of integrated project plans relevant to the deliverables and ensure alignment across relevant functions and a smooth transition among pipeline stages
•Manage multiple projects across several departments while influencing project decisions in coordination with Medical Affairs, R&D, Clinical, Regulatory Affairs, Quality, Manufacturing and Logistics timelines.
•Identify and implement solutions to improve tracking, planning and collaboration
•Ability to gain cooperation of others and effectively facilitates cross-functional meetings and discussions
•Ensure effective, accurate and timely communication across functional areas
•Serve as a primary point of contact for management regarding progress and goals
•Work with the team leaders to identify and resolve any team and individual performance issues
•Bring a broadened business perspective to each project through an understanding of the inner-workings of Marketing, Quality, R&D, Finance, Regulatory, Manufacturing, Clinical, Medical Affairs, and Operations.
•Managing and coordinating the activities of a multi-disciplined project from concept to commercialization. Plan, develop, coordinate and direct engineers and other cross-functional team members to achieve project objectives.
•Bachelor's degree in Mechanical, Chemical, Electrical Engineering or related field required. Advanced degree in related field or business preferred.
•7-10+ years experience in device and/or drug development and project management within the device/pharmaceutical industry, or reasonable combination of the two.
•Must have a strong familiarity with the integration of requirements and deliverables associated with Design Controls (21CFR820.30) into the new product development process.
•Experience working in a highly government-regulated environment (FDA, MHRA, EMEA, TGA, etc.). Must have led a cross-functional project team through regulatory submission and product commercialization
•Must have experience with short release cycles & experience leading large global programs
•Global product development and team management experience is a plus.
•Demonstrated success in large Project/Program Management role including Development and Deployment, preferably healthcare, or closely related is a plus.