Program Manager

About the role

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.

Responsibilities

• 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
• Avoidance of delays and ensuring 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

Requirements

• 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

Preferred Qualifications

• 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