Edwards Lifesciences Principal Engineer, Clinical Development (Transcatheter Mitral & Ticuspid Therapies) in Irvine, California
This is a unique opportunity to play a critical role in the growth of new cutting-edge heart valve therapies for Mitral & Tricuspid Valve Repair and Mitral Valve Replacement. We are seeking talented and passionate professionals to join this fast-paced, dynamic team and play a pivotal role in the development of new therapies and devices, from concept through to human use.
Initiate and lead in the improvement, design and optimization of highly complex experiments and tests, analyze results, provide complex recommendations, and develop reports, based on engineering principles that translate to innovative products
Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications
Oversee R&D support tasks; give instruction to technicians/engineers on conducting tests; train technicians/engineers and provide feedback; and coordinate technician/engineer work.
May lead cross-functional teams through complex design control activities including requirement specs, and risk documents with substantial knowledge on design control requirements
Develop project plans to assess complex technology and drive project results
Provide direction and guidance on strategies related to technical solution areas
Proactively identify issues, achieve resolution, and resolve problems of highly significant complexity on designing parts, components and subsystems
Train, coach, and guide lower level employees on more complex procedures
Other incidental duties
Minimum Education & Qualifications:
Bachelor's Degree in Engineering or Scientific field with a minimum of 8 years of relevant experience; OR Master's Degree in Engineering or Scientific field with a minimum of 7 years of relevant experience; OR a Ph.D. in Engineering or Scientific field with a minimum of 4 years of relevant experience
Strong in-depth experience and knowledge with root cause analysis and investigative techniques
Experience working within a highly regulated industry
Additional Skills & Preferred Qualifications:
Medical Device, Pharma, Biotech, Aerospace, or Automotive industry experience
Clinical development and design validation strategy experience
Leading and/or providing support with New Product Development & Improvement (Class III devices highly preferred)
Experience collaborating with physicians and collecting feedback on clinical use of products
Familiarity and strong knowledge of Risk Management and Usability Engineering
Experienced in driving complex medical devices from concept to market
Working in cross-functional teams and proven ability to cultivate collaboration across multiple disciplines (marketing, regulatory, quality, product design, engineering, and human factors) to ensure project success
Willingness and ability to mentor less experienced engineers
Ability to travel between 25% - 40% (internationally and domestically)
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.