Edwards Lifesciences Senior Engineer, R&D in Irvine, California
We are looking for a Senior Engineer, R&D 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 Sr Engineer will play a key role in design and development of new vascular access devices while working closely with a broad cross-functional team that includes Valve and Delivery System R&D, quality, clinical affairs, regulatory affairs, operations and marketing, as well as interacting with clinical specialists and physicians.
Create/update design control documents including requirement specs and risk documents
Create, test, and/or improve products by developing moderately complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles
Generate work instructions, test methods, engineering drawings/prototypes, etc. to establish/characterize product and/or process specifications
Assign R&D support tasks; gives instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers
Evaluate input and form a technical recommendation including designing parts, components and subsystems
Other duties assigned by Leadership
Education and Experience:
- Bachelor's Degree or equivalent in Engineering or Scientific field, at least 2 years of experience required in Engineering or Scientific field including internship
Experience in drafting design control documents
Experience designing prototypes and fixtures
Strong mechanical knowledge
CAD experience/ aptitude required
Good digital literacy in usage of MS Office Suite
Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
Basic understanding of statistical techniques
Previous experience working with lab/industrial equipment required
Solid problem-solving, organizational, analytical and critical thinking skills
Knowledge of and alignment to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
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
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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.