Project Engineer

Join us today and make a difference in people's lives!
 

LivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems.  The company is listed on the NASDAQ stock exchange under the ticker symbol “ LIVN .”  LivaNova is headquartered in London (UK) with a presence in over 100 countries and a team of more than 3,000 employees worldwide.

POSITION SUMMARY

This position is responsible for support of processes related to global regulatory operations and fast impact projects as described below. This position reports to R&D Fellow, Neuromodulation

This position is responsible for:

• External Documents:  administration of global processes for the monitoring, control, and communication of external documents applicable to LivaNova medical devices (e.g. international standards, medical device laws and regulations, regulatory guidance);

• Fast Impact:  manage and provides leadership to cross-functional teams to develop and execute on sustaining, continuous improvement regulatory compliance, etc. projects identified through the fast impacts project process. This position is responsible for managing resources with the Project Management Office to ensure that programs our sufficiently resourced to meet milestones and deliverables.

PRIMARY ACTIVITIES/DUTIES  

• Responsible for execution of global external documents process, including periodic screening meetings and associated tasks

• Responsible for generating/updating data and metrics used to update senior management on a periodic basis

• Identifies procedures and best practices for control of external documents

• Identifies and drives efforts for continuous improvement

• Identifies procedures and best practices for control of external documents

• Develops detailed plans in alignment with strategic objectives of the program, including master schedules, budgets, program milestones, and key program tasks and deliverables

• Provides guidance and direction to core team as necessary to define clear goals and to evaluate progress

• Identifies and assists in clearing barriers to effective progress

• Resolves program resource issues and facilitates reallocation of activities and efforts to ensure schedules are achieved

• Facilitates all core team meetings and tracks progress against the project plan and budget

• Complies with US FDA regulations, other regulatory requirements, Company policies, operating procedures, processes and task assignments.

• Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors and vendors

TRAVEL REQUIREMENTS

This position may require business travel.

MINIMUM REQUIREMENTS AND QUALIFICATIONS

• Education: Bachelor’s degree (or equivalent) in engineering or science

• Resourceful, creative, well-organized with an ability to prioritize and proactively offer solutions

• Ability to work effectively within a team in a fast-paced changing environment

• Ability to work in a highly matrixed and geographically diverse business environment

• Excellent verbal and written communications with ability to effectively communicate at multiple levels in the organization

• Prioritizes and meets deadlines in a timely manner

• Proficient in MS Office tools (Outlook, PowerPoint, Word, and Excel)

• The minimum requirements, skills and qualifications contained in this job description outline the core functions and requirements of the position and do not constitute an exhaustive listing of activities, duties, or responsibilities that may be required of or assigned to an employee in this position at the Company’s discretion. Further, the ability to meet the minimum requirements and/or possession of the stated skills and qualifications do not imply or establish that an individual will be employed in this position.  

DESIRED SKILLS AND QUALIFICATIONS

• BS degree in related Engineering discipline

• Knowledge and understanding of medical device related standards used medical device quality systems, and in the design, development, and distribution of medical devices

• Significant experience working in a broader enterprise/cross functional business preferred

• Experience with project management tools such as MS Project

• Experience in re