Edwards Lifesciences Engineer II, Process Development in Irvine, California
This is an excellent opportunity to contribute to a high energy, cross functional team environment including R&D, Manufacturing, Regulatory, and Quality, to ensure project objectives are met.
The Engineer II, Process Development will support the Global Supply Chain (GSC) by contributing in the commercialization of new products and the design transfer of new manufacturing processes within in our Global Valve Network. The Engineer II will integrate both New Processes and Operational needs to develop a robust manufacturing process with respect to the expected capacity to support the Global Supply Chain strategy. In this role you will report to the Principal Engineer, Process Development.
Transfer product/Processes from R&D to Manufacturing using project management, design for manufacturability and cost, process/design excellence, LEAN, ergonomics and knowledge transfer methodologies to ensure effective implementation of equipment, processes, and new technology.
Development of process specifications which ensure user needs are met.
Perform Equipment and process qualifications (IQ/OQ/PQ).
Collaborate with cross functional team to meet project deliverables.
Accountability (including hands on and resourceful) on troubleshooting, problem solving, and escalation of program risk to management when design transfer and scale-up to manufacturing do not work as expected.
Perform other duties and responsibilities as assigned.
A Bachelor's degree in engineering discipline is required; preferably Mechanical, Biomedical, or Chemical Engineering.
A minimum of 2 years of experience in medical device manufacturing is required.
Experience with key technologies and processes related to the assembly and manufacture of heart valves, surgical instruments, stents, catheters, delivery systems, and/or interventional devices is preferred.
Experience with use of process and design excellence methodologies including Six Sigma.
Familiarity with Design for Manufacturability, and LEAN experience leading to manufacturing efficiency improvement.
Ability to develop process specifications, collaborate with outside design firms and work with Operations personnel.
Knowledge of cGMP, EHS guidelines, FDA guidelines, and Process Validation.
Capable of analyzing and solving complex problems through innovative thought and experience.
Strong verbal/written communication and interpersonal skills including conflict and relationship management.
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 13,000 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.