Project/Program Manager

Hi, Hope you are doing well. This is

• Looking for Program Manager to support large New Product Development program.
• Familiarity with product development of high volume disposable medical devices strongly preferred.
• Same for work experience in production ramp-up and market introductions.
• 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 and decision making 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 Marketing, Medical Affairs, R&D, Clinical, Regulatory Affairs, Quality, Manufacturing and Logistics.
• 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 and matrix.
• Serve as a primary point of contact for management regarding progress and goals.
• Work with the functional 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.

• A minimum of a Bachelor’s degree
• A minimum of 5-7 years of Project Management experience.
• A minimum of 13+ years related work experience in product development.
• Demonstrated success in several large Project/Program Management roles including Development and Deployment, preferably healthcare, or closely related is a plus.
• Experience leading large global programs with distributed teams and leadership.
• Excellent interpersonal, communication, presentation and influencing skills Ability and willingness to travel occasionally.

• PMP certification High volume device and/or drug development and project management within the medical device/pharmaceutical industry, or reasonable combination of the two Strong familiarity with the integration of requirements and deliverables associated with Design Controls (21CFR820.30) into the product development process.
• Experience with short release cycles Experience managing ambiguity and providing clarity for teams.
• Experience working in a highly government-regulated environment (FDA, MDR).
• Must have led a cross-functional project team through regulatory submission and product commercialization.
• Demonstrated learning agility of new subject matter.
• Demonstrated application of product development and project management best practices on recent programs.
• Experience working in a highly government-regulated environment (FDA, MDR).
• Not looking for an IT or Finance PM. Prefer candidates that are local, project position.
• Open to direct report working remote, however prefer onsite.