R&D Project Manager, Urology

Position Summary

Principal Responsibilities

1. Responsible to deploy key project schedules and to meet project phase deliverables and milestones.
2. Develop scope, design, cost estimate and implementation plans for major projects and lead multiple concurrent projects. Analyze plans to ensure that they are feasible within resource
constraints. Review and adjust plans to meet overall business objectives. Define key results or objectives of project assignments and communicate roles and responsibilities to appropriate staff. Obtain resources (funding, staff, materials, equipment) necessary to complete key projects.
3. Maintain sustaining - compliance project governance.
4. Lead multi-functional and diverse leadership team comprised of Quality Assurance, Global Supply Chain, R&D, Purchasing, and leaders.
5. Develop scope, design, cost estimate and implementation plans for major projects and lead multiple concurrent projects. Analyze plans to ensure that they are feasible within resource constraints. Review and adjust plans to meet overall business objectives. Define key results or objectives of project assignments and communicate roles and responsibilities to appropriate staff. Obtain resources (funding, staff, materials, equipment) necessary to complete key projects.
6. Identify and implement cost reductions and develop and handle the annual project capital budget
7. Collaborate with project team, business unit, and workstream/shared services leads, as well as functional leaders from operations, regulatory, quality and clinical functions to finance to ensure efficient execution of a shared strategy.
8. Ensure overall compliance; promote creative solutions; ensure on-time completion of individual tasks and project workstream goals.
9. Support the development of harmonized business processes and procedures for execution and compliance with EU MDR, FDA, other external standards and regulations.
10. Communicate effectively with leadership to ensure clear expectations, demonstrate progress and identify issues. Provide progress updates and regular reporting to business and functions
leadership.
11. Through the implementation of project management and productivity tools, maintain and track progress and produce applicable reports.
12. Partner with other project leaders to ensure coordination of activities and timelines, facilitating efficient use of resources.
13. Partner with Quality, Operations and Regulatory as well as IT project management to develop systems and IT tools requirements to support effective standard processes.
14. Facilitate regularly scheduled meetings, take meeting minutes with action items, and follow up with SMEs on expected deliverables

Education / Experience Requirements

Qualification: 
Bachelor’s degree in a business or science discipline or equivalent education/experience required.

Experience
a) Minimum 3 years project management experience in the medical device and/or FDA regulated industry.
Minimum 5 years project management experience in large organizations with national or global operations.
b) Knowledge and application of a disciplined project management process.
c) Six Sigma and PMP certifications a plus.
d) Must have R&D and RA experience/knowledge and relevant experience in project management and process improvement skills.
e) Strong influence management skills. Demonstrated ability to work cooperatively at all levels in a matrix organization to build and maintain the positive relationships required to accomplish project goals.
f) Excellent verbal/ written communication and presentation skills.
Demonstrated ability to succinctly and accurately communicate to various levels of management and across the organization
g) Ability to support multiple projects and balance priorities, work independently or collaboratively to determine and develop solutions
h) Exceptional facilitation, analytical, planning, organization and time management skills to effectively execute project plans
i) Excellent decision-making skills. Ability to negotiate and balance decisions and manage competing priorities across multiple functional areas
j) MS Project, Excel, PowerPoint, SharePoint

Specialized Skills / Other Requirements