Engineering Program/Project Manager is responsible for managing the execution of programs and/or projects consisting of single or multiple projects and/or programs. Works within the constraints of budget, schedule, and scope, while managing risk, and ensuring adherence to established processes and methodologies.

 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 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.

Qualifications:

• Bachelor’s degree or equivalent experience in related field required
• A minimum of 7+ years related work experience required
• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering or related field required. Advanced degree in related field or business preferred.
• A minimum of 13+ years related work experience required 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.
• Must have experience with short release cycles.
• Demonstrated success in large Project/Program Management role including Development and Deployment, preferably healthcare, or closely related is a plus.
• Experience leading large global programs.
• Experience managing ambiguity and providing clarity for teams.
• Demonstrated learning agility of new subject matter.
• Excellent interpersonal, communication, presentation and influencing skills
• Global product development and team management experience is a plus.
• 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