ABBOTT LABORATORIES Program Manager-R&D Program Management Salary in the United States

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Position Summary:

We are seeking an experienced, high caliber Program Manager-R&D Program Management to join our team in the St. Paul, MN location.  In this role, you will work with new product development teams to plan, develop, gain regulatory approval, and commercialize state of the art therapies in Mechanical Circulatory Support for Heart Failure patients and customers. 

Primary Responsibilities:

• Manages complex, implantable device projects within the B/U.
• Assures the development of multi-level project planning to achieve short and long-term business objectives
• Develops, tracks and reports on all key product development and technology development programs.
• Keeps senior management team informed of design/development progress and issues.
• Develops functional departmental budgets and coordinates cross-functional project budgets
• Develops and communicates key performance indicators (cost/schedule/technical/quality) for projects.
• Provides design/development teams with appropriate resources to perform assigned tasks.
• Interfaces with appropriate internal and external resources to ensure intellectual property is protected.
• Interfaces with appropriate internal and external resources (regulatory, customers, etc.) to ensure development programs meet regulatory and customer requirements.
• Guides development and documentation of test plan protocols, standard operating procedures, specifications and test procedures.
• Participates in review boards for CAPA, complaints, business unit planning, and others as necessary.
• Reviews and provides functional approval for project and quality system documentation.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications:

• Bachelor’s Degree in a technical field (i.e. Sciences, Engineering) or related discipline
• 8+ years of medical device development experience and managing complex, multi discipline (electrical, software, mechanical) devices, including Class 3 implantable medical devices/systems
• Experience with Cyber-security
• Managed cross discipline (Clinical, Regulatory, Operations, R&D, etc) development teams and/or programs
• Working knowledge and experience with 21 CFR 820.30 and European Medical Device Directive (application to medical devices)
• Proficient with MS Project, Excel, and PowerPoint
• Budget planning and management experience
• Excellent verbal and written communication skills, with ability to communicate to all levels of the organization
• Experience collaborating with cross-functional teams in a geographically diverse, matrixed organization
• Ability to travel 20% of the time

Preferred Qualifications:

• Advanced level degree in technical and/or science field or related discipline
• PMP certification
• Experience in clinical settings/operating room
• Regulatory body interaction – FDA, Notified bodies, etc.
• Upstream market and product development experience