Edwards Lifesciences Senior Operations Integrator - Critical Care in Irvine, California
The Sr. Engineer, Ops Integrator for Value Engineering will contribute to the redesign of established Critical Care products for greater value and lower cost. The Ops Integrator Engineer will support Critical Care Operations by ensuring device design adheres to principles of DFM and leverage existing manufacturing processes, as well as designing new ones. In this role you will also be responsible for setting up product configurations, coordinating between the project team and the existing supplier base, EW supply chain, and launch phase-in/ phase-out strategy. You will be responsible for bringing issues related to all aspects of operations from the team into the broader EW organization and will be accountable to the team for performance of appropriate operational and supply chain activities by the extended team members.
Support design projects for established products targeted to add value, stay current with regulatory requirements, and proactively pre-empt obsolescence.
Create, characterize and implement new processes or process improvements required for value improvement.
Develop operational strategies to manage complex manufacturing process design, development and validation efforts.
Lead Ops Integration efforts to complete deliverables necessary for Value Engineering and integration into existing operations.
Work and effectively communicate in a high energy, cross functional team and multiple site environment which includes product design, regulatory, quality, procurement, configuration management, supply chain, supplier quality and operations to ensure project objectives are met.
Drive incorporation of technical advancements into manufacturing process and technology employed in the manufacture of existing products while improving value.
Continuously improve existing materials, manufacturability and sustainability.
Be the subject matter expert in key disciplines related to the manufacture of Class I, II and III medical devices.
Perform other duties and responsibilities as assigned.
Bachelor's degree in Engineering.
A minimum of 4 years of experience (with a bachelor's degree) in the medical device industry with key technologies and processes related to the assembly and manufacture of Class II or III cardiovascular devices is required.
Preferred degree in Mechanical, Electrical, Materials, Chemical, or Biomedical Engineering.
Demonstrated use of process excellence methodologies and applied statistics.
Demonstrated use of Design for Manufacturability, Industrial Engineering and LEAN experience leading to manufacturing efficiency improvement.
Effective knowledge transfer experience.
Knowledge of cGMP, EHS guidelines, FDA guidelines, Supplier Quality and Process Validation.
Capable of analyzing and solving complex problems through innovative thought and experience.
Demonstrated strong project management skills leading to cost savings.
Strong communication and interpersonal skills.
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.