Senior R&D Project Manager, Tracheostomy

Position Summary

Principal Responsibilities

1.    Lead end-to-end execution of complex, cross-functional and cross-BU R&D projects and programs.
2.    Build team ownership and commitment to project and business plans and define project milestones, deliverables, and associated resource requirements.
3.    Ensure alignment of R&D initiatives with business objectives and portfolio priorities.
4.    Actively build and foster collaborative relationships across all levels to improve overall outcomes and timely project/ program execution.
5.    Support R&D portfolio planning, prioritization, and capacity management
6.    Participate in Front End Innovation (FEI) activities for the New Product Development pipeline, including market research, concept generation and development
7.    Prepare and present project and portfolio status to senior leadership and governance boards
8.    Own and manage the initiation, planning, executing, monitoring & controlling and closing of Tracheostomy Sustaining and NPD projects. Create project plans, charters, schedules, budgets and other project specific documentation, as required.
9.    Ensure alignment and governance to NPD and Sustaining business processes and Quality System requirements for Design Control.
10.    Engage the appropriate technical resources and departmental leaders to identify deliverables, resources requirements, milestones, timelines, risks, and mitigation plans.
11.    Own and execute technical deliverables within the project as required.
12.    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.
13.    Ensure overall compliance; promote creative solutions; ensure on-time completion of individual tasks and project workstream goals.
14.    Lead/ coordinate project activities with Regulatory Affairs, Clinical Medical Affairs, Sterility Assurance, Global Packaging, Global Biocompatibility, and other shared service teams as required.
15.    Communicate effectively with leadership to ensure clear expectations, demonstrate progress, and identify issues and risks, along with their associated mitigation, escalation or resolution. Provide progress updates and regular reporting to business and functions leadership.
16.    Through the implementation of project management and productivity tools, maintain and track progress and produce applicable reports. 
17.    Support technical file preparation, regulatory submissions and audits as required. 
18.    Plan and oversee the implementation of new components/modified designs with strategic sourcing and manufacturing project leads.
19.    Document all new ideas for products and/or processes which should be assessed for  intellectual property opportunity. Work with the legal team to file new patents and assess potential for infringement 
20.    Partner with other project leaders or project managers to ensure coordination of activities and timelines, facilitating efficient use of resources.
21.    Partner with Quality, Operations and Regulatory as well as IT project management to develop systems and IT tools requirements to support effective standard processes.
22.    Mentor and coach Project Managers and R&D team members, drive lessons learned  and best-practice sharing across the entire team.
23.    Actively build and foster collaborative relationships across all levels to improve overall outcomes and timely project/ program execution.
24.    Any other assignment / task as deemed required to meet project deliverables

Education / Experience Requirements

Qualification    :    
      a) Bachelor’s degree in business or science discipline or equivalent education/experience required.
      b) PMP or other formal Project Management Certification preferred. 
 
Experience    
     a)    8-10 years of engineering and/ or project management experience preferably in the Medical Device or other regulated industry. PMO leadership experience preferred.
     b)    Proven track record managing complex, cross-functional R&D projects
     c)    Excellent stakeholder management, communication, and leadership skills 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)    Strong 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 devices would be an advantage

Specialized Skills / Other Requirements