Edwards Lifesciences Manager, Test Engineering - Critical Care Electronics NPD (Irvine, CA) in Irvine, California
Manager, Test Engineering, GSC / Critical Care
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 Global Supply Chain team and support the Critical Care division. There is a strong rate of innovation occurring in critical care, and this role directly supports that growth.
Essential Job Functions:
Leading and developing the capital electronics test engineering team that has responsibility to deploy ‘full stack’ manufacturing test solutions for a number of concurrent projects.
You will interface with engineering and operations teams early in the development cycles to develop efficient end to end test solutions and ensure a smooth deployment to our manufacturing supply chain.
You will work with internal and external partners on the design and deployment of complex factory test systems.
Work with production teams and vendors to scale and maintain factory test systems across multiple factories.
Driving optimizations in the various test processes to ensure product quality, and the operational efficiency.
Responsible for the growth, capability enhancement, and leadership development of the test engineers
Responsible for the strategic direction (insourcing vs. partnerships), budget, and business planning cycles
Bachelor’s degree in engineering or relative discipline plus 10 years relative experience required (or Masters Degree plus 8 years relative experience)
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 communicate (or translate) complex and technical information to all levels of the organizations.
Expert knowledge and understanding of principles, theories, and concepts relevant to Engineering.
Advanced problem-solving, organizational, analytical and critical thinking skills.
Travel up to 25% of the time to domestic contract manufacturers
Technical Must Haves:
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, RS422, USB, HDMI, TCPIP
Experience in system-level design and architecture, including schematics and board development, system bring up and debugging
Able to analyze the trade-offs between performance, manufacturability and cost
Proven expertise in usage of Test Stand & LabVIEW
Strong statistical (6-sigma / Black Belt) background
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.