Reporting directly to the Senior VP of Disposable Products Development, the Program Manager of Product Development will lead teams responsible for the overall execution of critical business programs from concept development through manufacturing transfer and commercialization.
Responsibilities will include management of disposable and capital equipment programs leading to the transformation of organ transplant in the US and worldwide.
This is a high visibility role, requiring decisive judgment and interaction with multiple internal and external teams. The program manager interfaces with all levels of management in fulfilling the planning, scheduling, organizing, directing and controlling of the development program. Leads engineering and cross-functional project team(s) to ensure all internal and external targets and objectives are completed effectively and in a timely manner. The ideal candidate is a technically capable, results-oriented leader with experience in successfully executing medical device product development programs.
ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:
Leadership role responsible for managing product development programs.
Lead and coach internal and external technical resources to support programs.
Work collaboratively with product development, manufacturing engineering, operations,
regulatory affairs, clinical affairs, sustaining, product specialists and quality teams to execute programs on time and on budget.
Build and implement program management tools and processes to effectively execute programs.
Timely tracking and presentation of program status.
Participates in the creation of the program objectives and overall project scope.
Ensures that projects are managed within project timeline and budget baselines.
Ensures compliance with the TransMedics Quality System and PDP.
Monitors and reports project status to Senior Management, other Stakeholders
Works independently and with the project teams to develop, maintain, and align an accurate, integrated project timeline, and resource plan.
Understands critical path activities, anticipates risks, and creates contingency plans in
collaboration with project teams.
Generates analysis of timeline, and resource information that facilitate scenario planning,
contingency planning, risk assessment and management, problem solving, and decision making.
Manages engagements with outside engineering partners as necessary to design, build, and test custom medical device systems, subsystems, and software.
Perform other TransMedics tasks and duties as required.
REQUIREMENTS:
8+ years of experience working in an FDA/ISO regulated medical device/medical equipment environment.
5+ years of experience preferred managing technical teams and programs.
Detail oriented with strong organizational skills.
Strong leadership and interpersonal skills.
Strong program management skills with accountability for budgets, milestones, and deliverables.
Excellent verbal and written communication skills.
Effective analytical and decision-making skills.
Must have a proven history of working in a fast-paced environment with a demonstrated ability to adjust to changing priorities.
Experience with design, manufacture, and commercialization of disposable and durable perfusion products preferred.
Understanding of regulatory procedures/standards
Ability to manage teams and individuals in a matrix environment, ability to track team performance against objectives, use of effective meeting management tools and techniques, and knowledge of decision-making and conflict resolution techniques.
An Expert or Power User level project management related software/tools to facilitate: Scheduling, Tracking project tasks and milestones o Resource utilization o Management Reporting
EDUCATION:
BS in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or equivalent is required.