Edwards Lifesciences Principal Electrical Manufacturing Engineer - Critical Care in Irvine, California
The Principal Electrical Manufacturing Engineer is an exciting opportunity to collaborate on projects and initiatives in support of Edwards Lifesciences Advanced Hemodynamic monitoring systems. This position will play a key role in the development and execution of the manufacturing and operations strategy, including leading key projects and initiatives, supporting ongoing manufacturing, new product commercialization, line extensions, interfacing with third party providers, and leading product and process improvements.
The Staff Electrical Manufacturing Engineer’s responsibilities will include:
Apply knowledge of technical principles and process excellence (Lean / Six Sigma) to define, develop, maintain and optimize manufacturing and service processes for Critical Care’s Electronics Business.
Use technical principles, problem solving skills, and data analysis to support and problem-solve for production and service at local, global, and third party suppliers through a robust supplier interface.
Drive incorporation of technical advancements, product improvements, and cost reductions through manufacturing enhancements, product changes, and part qualifications.
Work and lead initiatives to support manufacturing projects and goals (material qualification, supplier changes, part changes, product changes, product enhancements, equipment qualifications) through technical advancements, problem solving skills, and process excellence methodologies.
Lead key project initiatives (supplier transfers, part changes, system enhancements, line extensions, cost reductions, labor efficiency improvements, and quality and compliance excellence).
Provide ongoing support and training to the production/service personnel on new processes, process changes, and systems to increase quality and productivity in the build, test, and servicing of electronics products.
Understand and maintain assembly, test, and servicing processes, equipment, and tools to ensure availability of tools and equipment for the operators as required for local and global sites.
Manage change control for ongoing manufacturing changes, including change requests, process changes, Device Master Record, product specifications, test processes, and product service processes.
Deploy, review, and act upon meaningful metrics to measure, control, define, refine, and optimize processes and for process control and continuous improvement.
Perform other duties and responsibilities as assigned.
Bachelor’s Degree in Electrical Engineering is required with a minimum of 8 years of relevant work experience; OR Master’s Degree in Engineering with a minimum of 7 years of work experience. Prior medical device industry experience is required.
Understanding of product and process change control, design control, MRP / Inventory processes, and Quality System requirements.
Familiarity with medical device regulations and governance documents (ISO13485, CFR820, etc).
Experience writing and executing protocols for validation of tools, fixtures, equipment, and process.
Must have the ability to train, coach and mentor operators on how to use the procedures effectively.
Capable of analyzing and solving complex problems through innovative thought and experience. Capable of making decisions based on data, analysis, and problem solving methods (ex: DMAIC) then acting quickly to deploy the resulting desired option.
Demonstrated experience with process excellence and continuous improvement in the manufacturing/service environment.
Experience working with suppliers of electronics components, subassemblies, and finished devices.
Experience writing, developing, and maintaining procedures for assembly, service, and test.
Strong communication and interpersonal skills. Ability to communicate clearly through presentations, written documents, and verbally.
Ability to perform root cause analysis and recommendations for non-conforming products.
Understanding of product and process change control, MRP / Inventory processes, and Quality System requirements.
Lean Champion and/or Six Sigma certifications preferred.
Ability to use Mechanical CAD tools (Solidworks or ProE).
Ability to read electronics schematics and mechanical drawings.
Experience troubleshooting and documenting evaluations of finished devices, sub-assemblies, and component failures.
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.