Edwards Lifesciences Principal Engineer - Transcatheter Heart Valve, R&D in Irvine, California
We are looking for a Principal Engineer for Edwards Lifesciences' Transcatheter Heart Valve (THV) Access team. The Access team is responsible for the development of sheath technologies for vascular delivery of our transcatheter devices to the patient. As the leading edge of the THV therapy, this position is uniquely positioned to interact with a wide range of THV technologies including valves, delivery systems and other procedure components. The Principal Engineer will play a key role in design and development of new and existing vascular access devices and test methods while working closely with a broad cross-functional team that includes Transcatheter Valve and Delivery System R&D, Quality, Clinical Affairs, Regulatory Affairs, Operations and Marketing, as well as interacting with clinical specialists and physicians.
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
Bachelor's Degree in Engineering or Scientific field with minimum of 8 years years of experience, including either industry or industry/education Required or
Master's Degree or equivalent in Engineering or Scientific field with minimum of 7 years years of experience, including either industry or industry/education Required or
Ph.D. or equivalent in Engineering or Scientific field with minimum of 4 years years of experience, including either industry or industry/education Required
Experience designing prototypes and fixtures
Experience with endovascular medical devices
Experience crafting parts for injection molding and extrusion is preferred
Proven expertise in usage of MS Office Suite
Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
Solid problem-solving, organizational, analytical, and critical thinking skills
Solid understanding of processes and equipment used in assigned work
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to handle competing priorities
Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
Ability to build productive internal/external working relationships
Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing is preferred
Every employee is essential to Edwards’ success, and we’re ready to help you advance along your career path!
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.