Mon - Fri, 8am - 5pm Qualifications:• University Degree (BA degree) required • Bachelor’s degree and a minimum of 7 years of related experience including broad multi-functional business experience along with 3+ years of project and/or people management experience. Master’s degree and a minimum of 4 years of related experience including broad multi-functional business experience along with 1+ years of project and/or people management experience. Preferred Education and Experience: MBA, Six Sigma Green Belt and PMP certification preferred. • Education requirements can be obtained through an educational institution or gained through equivalent work experience • Ability to apply considerable judgment in the planning, scheduling and coordinating of project phases and schedules. • Ability to create, lead, establish, maintain and influence effective working relationships with internal customers at all levels. • Ability to handle multiple priorities and to meet key deadlines under pressure through effective time management skills. • Ability to develop and manage policies and procedures that affect program management. • Ability to institute change • Ability to negotiate and manage competing priorities across multiple functions. • Ability to build credibility, establish rapport, and maintain communication with internal and external stakeholders at multiple organizational levels • Excellent decision-making skills ability to negotiate and balance decisions and priorities across needs of several functions. Ability to make timely decisions in the face of risk and uncertainty. • Exceptional analytical, planning, organization and time management skills to effectively execute project plans and budgets. • Strong business acumen; ability to think from an overall “best for the business” perspective • Demonstrated capacity for strategic thinking, project planning and project management. • Strong knowledge of design control process and FDA rules and guidelines for medical device industry • Advanced problem solving and analytical ability with strong attention to detail. • Well versed in the 10 project management knowledge areas • Strong influence management skills; ability to work collaboratively at all levels in matrix environment to build and maintain positive relationships required to accomplish organizational goals. • Excellent communication skills ability to succinctly and accurately communicate to various levels of management and employees. • Demonstrated ability to coordinate and lead cross-functional project team activities in an effective and efficient manner, requiring strong organizational, motivational and interpersonal skills. Responsibilities: •Works in concert with business and functional leaders to identify and manage risk assessment and communicate accordingly. • Guides and assists the program management group in continuous improvement initiatives. •Assists Director with PMO activities and initiatives as required •Manages complex issues requiring evaluation of broad factors, exercises judgment within broadly defined practices. • Ensures team deliverables are in compliance with the design control processes and meet the PRC’s expectations. •Provides the communication link between the project team and the BULT and DLT. •Manages project issues, decisions, risks, and escalation to management• Collaborates with finance to develop the ROI and manages the financial cost modelling. •Provides critical leadership to ensure overall quality of project planning and execution, while minimizing and mitigating project risks. • Develops project plans specifying goals, strategy, staffing, scheduling, identification of risks, contingency plans, and allocation of available resources leveraging team inputs and strengths. • Prepares a variety of periodic and ad hoc reports for business and functional leaders, and distributes appropriate project related data and documentation as appropriate • Presents periodic status reports on current initiatives to the executive management. •Manages cost, schedule, and performance of component projects while ensuring ultimate success of the program. • Provides direction and leadership to cross-functional teams while directing and managing project tasks involving initiation, planning, execution, monitoring, controlling, and closing. • Responsible and accountable for the coordinated management of multiple product development projects directed toward strategic business and other organizational objectives. • Responsible for achieving successful implementation of regional and global programs, and managing all activities required to define, design, develop and deliver new products or therapies. Provides direction and leadership to a cross-functional team including members with expertise from all areas involved in product development and commercialization. The Program Manager is accountable to the Phase Review Committee (PRC) for overall program execution and will be responsible for ensuring team commitments (project contract) are met and communicated in a timely manner.
