Program Manager

Job Description

Position Summary:

This is a leadership role responsible for working with cross-functional teams globally to ensure all dependencies/deliverables are available in a timely manner to provide smooth execution on various sustaining projects for BMT medical devices (capital equipment, consumables, software, and hardware).

The Program Manager will provide overall program strategies, project plans, resourcing, and execution to align with corporate strategies and roadmap and to ensure products' changes meet performance and regulatory requirements and compliance in various markets. The Program Manager will manage a cross functional team of R&D, Operations, marketing, Quality Engineers, and Regulatory Associates to lead program related activities to the finish line. The program manager will coordinate activities with external vendors and suppliers as needed.

Primary Duties and Responsibilities

Manage and lead sustaining engineering projects:

• Lead strategies, planning, and execution of the various sustaining projects
• Define project scope, goals, and deliverables in collaboration with department management, senior management and stakeholders
• Develop full scale project plans
• Define project tasks and resource requirements
• Secure needed resources and manage the budget
• Assemble and coordinate project tasks and deliverables
• Identify and resolve issues and conflicts within the project team
• Liaise with project stakeholders (internal and external) on an ongoing basis
• Track project deliverables using appropriate tools
• Proactively manage changes in project scope, risk and issues, and devise contingency plans to achieve project output
• Provide direction and support to project team and influence them to take positive action and accountability for their assigned work
• Ensure the technical files and design history files are properly maintained
• Work as a liaison between the project team, R&D, Operations, Manufacturing, Quality, Supply Chain, and regulatory functions, and Senior Management
• Report on project and team progress, recommendations, and issue resolution at senior management meetings
• Collaborate cross-functionally ensuring common focus and understanding of project goals
• Clarify options and issue resolution recommendations to ensure effective senior management reviews and decision making.
• Participate in long term product line strategy development to understand unmet needs related to product lines within defined scope of responsibility
• Pursue continuing education and training

Required Skills

Minimum

• Bachelor's degree
• 5+ years direct work experience in project management capacity and/or people management
• 5+ years medical device industry experience
• 5+ years technical experience in one or more areas of development of sterile single use medical devices and/or electro-mechanical systems and/or software development
• Working knowledge and experience with quality systems regulations and guidelines, Medical Device Directive (MDD), Medical Device Regulations (MDR), General Safety and Performance requirements (GSPR), Design Controls, Design input and output verification and validation (IOVV), FDA
• Experience with project management tools
• Demonstrates organizational and time management skills
• Strong written and verbal communication skills and interpersonal skills to effectively transfer ideas, concepts and information
• Ability to work with various internal and external customers in a professional manner
• Proven experience to work cross-functionally across an organization
• Ability to communicate effectively across all levels of the organization

Preferred:

• Certification in project management or equivalent
• Previous experience leading software development teams

Other:

• 15% travel time may be required
• This position is expected to be Hybrid