R&D Project Manager, Tracheostomy

Position Summary

Principal Responsibilities

1.    Manage the development, planning, and execution of design-related projects (both NPD and Sustaining). Create project plans, charters, schedules, and other project specific documentation. Assess project feasibility, cost estimates and business impact and risks. 
2.    Ensure alignment and governance to corporate NPD and Sustaining processes.
3.    Engage the appropriate technical resources and departmental leaders to identify deliverables, resources requirement, milestones, timelines, risks, and mitigation plans.
4.    Own and execute technical deliverables within the project as required.
5.    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.
6.    Ensure overall compliance; promote creative solutions; ensure on-time completion of individual tasks and project workstream goals.
7.    Lead/ coordinate project activities with Regulatory Affairs, Clinical Medical Affairs, Sterility Assurance, Global Packaging, Global Biocompatibility, and other shared service teams as required.
8.    Communicate effectively with leadership to ensure clear expectations, demonstrate progress, and identify issues. Provide progress updates and regular reporting to business and functions leadership.
9.    Through the implementation of project management and productivity tools, maintain and track progress and produce applicable reports.
10.    Plan and oversee the implementation of new components/modified designs with strategic sourcing and manufacturing project leads.
11.    Create project charters in the project management database (Planview); maintain project information and provide status updates within database. Utilize various project management software and tools as required for project plan creation, scheduling and reporting.
12.    As required, coordinate a project portfolio review across multiple projects. This may include smaller technical projects led by engineering across a particular product family. Provide consistent high-level project leadership, maintain an understanding of project status, and report progress.
13.    Partner with other project leaders to ensure coordination of activities and timelines, facilitating efficient use of resources.
14.    Partner with Quality, Operations and Regulatory as well as IT project management to develop systems and IT tools requirements to support effective standard processes.
15.    Facilitate regularly scheduled meetings, take meeting minutes with action items, and follow up with SMEs on expected deliverables.
16.    And any other assignment / task as deemed fit.
 

Education / Experience Requirements

Qualification    :    
a)    Bachelor’s degree in a business or science discipline or equivalent education/experience required.
b)    Minimum 4 years’ experience in Project Management, PMP Certification preferred. 

Experience    
a)    Minimum 4 years project management experience preferably in the medical device and/or FDA regulated industry.
b)    R&D or engineering experience/knowledge and relevant experience in project management and proficiency in project management software and tools.
c)    Exceptional interpersonal and communication skills, with the ability to collaborate and influence at all levels of the organization 
d)    Excellent verbal/ written communication and presentation skills. Demonstrated ability to communicate to various levels of management succinctly and accurately and across the organization
e)    Ability to support multiple projects and balance priorities, work independently or collaboratively to determine and develop solutions
f)    Exceptional facilitation, analytical, planning, organization, and time management skills to effectively execute project plans
g)    Excellent decision-making skills. Ability to negotiate and balance decisions and manage competing priorities across multiple functional areas
h)    Self-motivated, high energy, positive attitude with initiative and drive for timely completion of goals
i)    Able to travel domestically and internationally
j)    Familiarity with ISO 13485, MDR, FDA 21 CFR Part 820 Design Control, ISO 14971, GMP and other standards as they relate to the development and manufacture of medical device would be an advantage
 

Specialized Skills / Other Requirements