Edwards Lifesciences Senior Product & Process Engineer (Draper Utah) in Salt Lake City, Utah
The Senior Product & Process Engineering role is a great opportunity to support Edwards Lifesciences’ dynamic and rapidly growing Global Supply Chain. As a Senior Product & Process Engineer, you will support existing manufacturing to ensure continuity, investigate and correct product and process non-conformities, implement process improvements to improve quality and throughput, support development of new processes in our Draper, UT facility, and support manufacturing transfer activities from and to our other manufacturing sites (primarily Irvine, CA, Shannon, Ireland, external manufacturing supplier).
In this role you will:
Lead investigations, analysis and problem-solving activities related to product and process deficiencies.
Partner with operations, supply chain, quality, and regulatory affairs to develop process changes; including the design, development and procurement of tooling, fixtures and equipment.
Maintain as a technical lead for the product transfer to external manufacturing supplier and/or receiving product from Irvine site
Creation and modification of detailed manufacturing instructions and electronic manufacturing execution systems to support new processes and equipment.
Layout of production workstations for product flow, ergonomics and efficiency.
Drive CAPA activities including verification, validation and implementation of improvements.
Resolve product, process, and equipment non-conformances in a manner which minimizes impact to manufacturing activities.
Ensure accuracy of FMEAs and Validation Plans.
Write and execute process validation protocols (IQ/OQ/PQ).
Manage product testing against approved protocols.
A bachelor's degree engineering with 4 years of experience.
4 years of experience working within a manufacturing environment, troubleshooting design, process, and/or product issues.
Engineering degree such as mechanical, or manufacturing engineering is preferred. An advanced degree is preferred.
Proficiency in mechanical assembly (press fits, adhesive bonding, fastener selection).
Strong communication skills are required.
Must have strong problem solving and analytical skills.
Understanding of statistical techniques is required.
Medical device manufacturing experience in heart valves, stents, catheters, delivery systems and/or interventional devices is preferred, but not required.
Able to work under pressure while managing competing demands and tight deadlines.
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.