Edwards Lifesciences is seeking a Sr. Manufacturing Engineering in our growing Extrusion area. This role is a great opportunity to support a dynamic and rapidly growing area within Edwards Lifesciences’ THV business unit. This position will support existing manufacturing to ensure continuity, monitor compliance, perform technical assessments of nonconforming product, implement process improvements to improve quality and throughput, and support development of new processes. This position will also support projects and transfers into our Draper, UT facility.
Lead investigations, analysis and problem solving activities related to design and process deficiencies.
Drive CAPA activities including verification, validation and implementation of improvements.
Resolve NCRs, ENCRs, and OOTs in a manner which minimizes impact to manufacturing activities.
Monitor and report on the effectiveness of implemented solutions.
Manage product testing against approved protocols.
Ensure compliance to quality requirements.
Ensure accuracy of FMEAs and Validation Plans.
Ensure equipment is being managed and maintained per validated requirements
Write and execute process validation protocols (IQ/OQ/PQ).
Required Education, Skills & Experience:
Experience in extrusion or similar processes is required.
A bachelor's degree in a related engineering field such as mechanical, industrial, or manufacturing engineering is required.
A minimum of 4 years of manufacturing engineering experience within a medical device, manufacturing environment, troubleshooting design, process, and/or product related issues is required.
Strong communication skills are required. Strong problem solving and analytical skills are a plus.
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.
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 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
Job Function Engineering - Manufacturing
Primary Location USA-USA-Utah - Draper