The role
0301Ensure effective collaboration across cross-functional device development teams, including Technical Development, Lifecycle Management, Core Teams, and external stakeholders, to drive successful execution of product development activities throughout the entire device lifecycle.
02Independently plan, coordinate, execute, and monitor project management activities within a regulated medical device environment, ensuring alignment with design control requirements, business objectives, timelines, budgets, and quality standards.
03Develop, maintain, and continuously update comprehensive Design & Development Plans, translating device strategies into actionable project roadmaps, defining deliverables, milestones, resource requirements, dependencies, and contingency plans.
04Drive project execution by facilitating team activities, monitoring progress against schedules, managing project scope, and ensuring the timely completion of design control and stage-gate deliverables.
05Support governance and compliance activities by guiding teams through business process stage-gates, preparing governance reviews, coordinating technical advisory meetings, and ensuring inspection readiness of project documentation.
06Identify, assess, and proactively manage project risks, issues, and dependencies by implementing mitigation strategies, facilitating risk management processes, and escalating critical concerns to leadership when required.
07Develop and implement communication strategies and reporting tools, including project dashboards, status updates, and stakeholder communications, to ensure transparency regarding project progress, risks, resource utilization, and key decisions.
08Facilitate effective decision-making processes by organizing and leading cross-functional meetings, documenting outcomes, tracking action items, and ensuring timely resolution of project challenges.
09Foster a collaborative, high-performing team environment by assessing team dynamics, promoting open communication, facilitating team-building activities, and strengthening relationships across functional teams and project stakeholders.
10Coordinate and integrate deliverables across multiple departments and partner teams, ensuring alignment of schedules, technical activities, and project objectives to support successful product development outcomes.
11Forecast, monitor, and manage project resources, budgets, and costs, providing accurate financial visibility and supporting informed decision-making regarding project priorities and resource allocation.
12Establish and maintain centralized knowledge management systems, ensuring team access to critical project information, maintaining project history files and document repositories, and supporting lessons-learned activities throughout project execution.
13Lead continuous improvement initiatives by analyzing project outcomes, implementing process enhancements, optimizing project management tools, sharing best practices, and driving organizational awareness of improved methodologies.
14Apply project management best practices, methodologies, and tools for planning, communication, collaboration, issue management, risk control, decision-making, knowledge management, and performance tracking to ensure efficient project delivery.
15Act as a backup to the Device Team Leader when required, supporting team communications, stakeholder engagement, governance activities, and overall project leadership responsibilities.
