Edwards Lifesciences Director, R&D Engineering in Irvine, California
As a 'Best in Class' Edwards Lifesciences - Transcatheter R&D organization we will pioneer 'First of a Kind' solutions, improve our products and procedures, launch high performance products, develop our engineers and technicians, be an 'Organization of Choice', and be energized by the opportunities to provide meaningful contributions every day. Join us as we put patients first!
This is an exciting opportunity for an experienced medical device Director, R&D Engineering , with strong technical experience and exceptional leadership skills to contribute to the leading-edge transcatheter heart valve program. This role is responsible for testing and analysis of frames and materials associated with the Edwards Transcatheter Heart Valve program in support of product development. This position will lead the development of testing strategies as well as formulate regulatory submission strategies in support of obtaining regulatory approvals worldwide.
Responsibilities include, but are not limited to:
Oversee execution of valve frame and materials testing and related activities to comply with FDA and ISO requirements
Develop overall test strategies for frames and materials
Oversee preparation of test data for Regulatory submissions
Develop innovative test strategies to shorten time to regulatory approvals
Support R&D efforts with test plans to verify performance of next generation technologies
Support Manufacturing efforts to incorporate technical advancements into the manufacturing process
Support Manufacturing efforts to implement quality improvement project
Ensure testing reports are accurate, analyzed appropriately and completed in a timely manner to meet project needs
Organize project and departmental objectives and manage resources effectively.
Bachelor’s degree in Material Science Engineering or a related Engineering field is required - advanced degree is a plus
12+ years of experience in an engineering capacity within the medical device industry including: in depth experience in the development and testing of high technology medical devices; advanced knowledge of material science (stainless steel, cobalt alloys, nitinol) and fatigue testing, including FEA
4+ years managing and developing talent - ability to lead and develop talent is essential
Must possess clearly recognizable technical qualifications and leadership skills
Strong background in heart valves or stents is preferred. Background with class III medical devices and knowledge of PMAs
Strong ability to partner with US and international R&D, QA, RA, and Manufacturing groups
Must have the ability to manage multiple projects.
Must have participated in GMP and ISO compliance audits
Ability to work effectively with others at all levels
Ability to travel both domestic and abroad
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 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 focus on helping patients regain and improve the quality of their life.