Summary and Scope of Position:
Support and manage daily development, commercial and project management activities in support of the INTERCEPT Blood Systems
- Ensures program scope includes input from all functional areas including Marketing, Engineering, Operations, Quality, Legal, Regulatory, and Service.
- Works with functional management to resolve ambiguous requirements and ensure that the best team structure and members are identified.
- Identifies key stakeholders and understands their expectations for a successful project.
- Builds integrated schedules and budgets, working with core team members to establish task durations and dependencies among tasks.
- Optimizes schedules to identify critical path(s) and major risks. Gains consensus on the integrated schedule, ensuring plans address the deliverables.
- Monitors progress on schedule, budget and technical output. Drives teams to execute on tasks and deliverables.
- Develops a sense of urgency when key deliverables are jeopardized. Facilitates problem solving and meetings to address obstacles.
- Relies on core team member and functional leader expertise when faced with critical decisions. Holds core team members accountable to program commitments.
- Facilitates communication to key stakeholders on project performance. Conducts project reviews and meetings with senior management.
- Proactively manages risks and employs strategies to address.
- Fosters teamwork; strives to maintain an environment of openness and trust.
- BS in scientific or engineering discipline preferred with a minimum of 5years of successful experience managing projects in a highly technical & regulated environment.
- PMP certification preferred.
- Strong experience with a Stage, Phase Gate development process.
- Exposure to hardware and software development, verification/validation and systems integration.
- Technically savvy; must be able to discuss, understand and make decisions regarding a wide array of engineering disciplines and complex technical/logistical issues.
- Expert-level skills using Project Management tools and techniques. Adept in the use of key project performance indicators. Must have successfully managed multiple commercialization projects.
- Excellent communication and interpersonal skills, negotiating; managing change; goal setting; planning and organizing; teamwork; ability to address difficult situations; able to understand technical information .
- Must possess managerial courage; must be confident managing risks and making decisions that will likely have a large impact on organizational objectives.
- Ability to manage matrixed and multi-site teams comprised of individuals with diverse backgrounds; including Hardware, Software, Regulatory, Operations, Quality, Service and Marketing.
- Ability to interact effectively with Marketing to ensure that project scopes and requirements are clearly defined and executable. Must possess the communication and personal skills required to resolve ambiguous and conflicting requirements.
- Provide leadership to core team members and provide feedback to functional leaders regarding team performance.
- Negotiate and resolve project conflicts and drive consensus among team/functional leaders to accomplish project and business goals.
Foster continuous improvement in the organization’s ability to execute projects, throughout the stage-gate product development process.