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Title: R&D Manager, Engineering - Transcatheter Heart Valve Location: USA-California - Irvine Job Number:_001672 Edwards Lifesciences has an exciting opportunity with the Transcatheter Heart Valve team currently involved in designing and developing cutting edge products.
Primary responsibilities will include:
* Lead engineering team in support of product development and ensure all work is performed per internal, ISO and regulatory standards * Manage the collaboration of core team, cross functional team members, external partners, suppliers and Key Opinion Leaders (KOPs) * Provide timely and innovative resolutions to technical issues that can be called upon from a regulatory perspective * Provide leadership to engineering core team in the development and implementation of new ideas and concepts for current and future product lines * Provide updates and recommendations for various inter-departmental issues, as well as program related needs * Manage and anticipate budget needs and support budget planning process
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that save and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs about 7,000 individuals worldwide.
For us, helping patients is not a slogan - it''s our life''s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we help ensure that patients regain and even improve their quality of life.
Required Skills, Experience and Education:
A minimum of 8-10 years experience and two years management experience in the Medical Device arena is required. A bachelors degree in Engineering discipline is required. A master''s in Engineering or Engineering Management preferred.
* Project management skills/tools to facilitate project tracking is essential * Strong technical experience/knowledge of catheter, surgical tool equipment, and balloon experience preferred * Ability to work in a fast-paced environment * Must have great interpersonal skills * Excellent communication skills, written and verbal * Ability to interface with external customers, project teams, and all levels of management * Proven track record of developing teams and motivating employees to achieve company goals * Proven track record of developing product from concept phase to commercial launch * Familiarity with various ISO standards, design control and various regulatory agency requirements