Edwards Lifesciences Senior Engineer, Test Engineer - Critical Care in Irvine, California
This role is an exciting opportunity that will provides expertise, leadership, and guidance in the development, and manufacture of life-sustaining critical care capital equipment. This role will join Edwards Critical Care division that is innovating at a rapid pace and seeking a seasoned veteran to support the Operations Team.
Essential job functions include:
Drive the development and deployment of highly complex service and production testers and post bring-up tester debug and yield improvements
Act as the technical SME for electronics testing and failure analysis of service center and production failures.
Experience in system-level design and architecture, including schematics and board development, system bring up and debugging
Experience in documentation, test requirement specifications, change control process, and tester and software validation
Maintaining tester change control and spare part management
Experience in the design and development of digital/analog boards and systems suitable for high mix testing
Experience with IPC-610 and its application in PCBA manufacturing
Experience with a host of communication protocols; I2C, SPI, RS232/RS422/RS485, USB, HDMI, TCPIP
Experience with wireless communication protocols
Able to coordinate and manage development of fixturing necessary to support test stands
Experience with the manufacturing process and design rules for PCBA, Flex Circuitry, System on Chip, Molding, Batteries, Pneumatics, and other relevant medical technologies etc.
Hands-on experience with sensor technologies and architecture
Able to analyze the trade-offs between performance, manufacturability, and cost
Perform other duties and responsibilities as assigned.
Bachelor’s degree in engineering or equivalent experience working within an engineering or scientific field, EE strongly preferred
Proven expertise in LabVIEW and TestStand for test development and debugging.
Proficient in usage of DMM, power supply, oscilloscope, and other lab equipment.
Experience in usage of MATLAB, Spice, and Altium other simulation/modeling tools
Familiarity with medical device regulations and governance documents (ISO13485, CFR820, IEC 60601-X).
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills.
Ability to translate complex and technical information to all levels of the organizations.
Recognized as an expert in own area within the organization while applying broad-based technical expertise and has full knowledge of other related disciplines.
Expert knowledge and understanding of principles, theories, and concepts relevant to Engineering.
Advanced problem-solving, organizational, analytical, and critical thinking skills.
Expert understanding of processes and equipment used in assigned work.
Strong leadership skills and ability to influence change.
Ability to interact professionally with all organizational levels in a cross-functional team.
Represents organization as key technical contact on contracts and projects.
Interacts with senior external representatives on significant technical matters often requiring coordination between organizations.
Travel up to 25% of the time to domestic contract manufacturers
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.