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Edwards Lifesciences Senior Engineer – Transcatheter Heart Valve, R&D  in Irvine, California

We are looking for a Senior 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 Senior Engineer will play a key role in design and development of new and existing vascular access devices 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.

Key Responsibilities:

  • Create, test, and/or improve products by developing complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles

  • Experience with molded plastics, plastic extrusion and metals

  • Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications

  • Create/update more complex design control documents including requirement specs, and risk documents

  • Develop and execute engineering project plans

  • Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers

  • Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work

  • Evaluate input and form a technical recommendation including designing parts, components and subsystems

  • Train, coach, and guide lower-level employees on routine procedures

Required Qualifications:

  • Bachelor's Degree in Engineering with 4 years of experience - OR - Master's Degree in Engineering with 3 years of experience - OR - Ph.D. in Engineering

  • CAD experience/aptitude

  • Basic understanding of statistical techniques

  • Previous experience working with lab/industrial equipment required

  • Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills

Additional Qualifications:

  • Experience designing prototypes and fixtures

  • 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.

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