Principal Electrical Manufacturing Engineer - Critical Care
Company: Edwards Lifesciences Gruppe
Posted on: April 8, 2021
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account. Thank you for your patience. Principal Electrical
Manufacturing Engineer - Critical Care USA - California - Irvine
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 Principal Electrical Manufacturing Engineer's responsibilities
- 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
- 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
- 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
- Lead key project initiatives (supplier transfers, part changes,
system enhancements, line extensions, cost reductions, labor
efficiency improvements, and quality and compliance
- 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
- Manage change control for ongoing manufacturing changes,
including change requests, process changes, Device Master Record,
product specifications, test processes, and product service
- 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 Engineering is required (Electrical
preferred) with a minimum of 8 years of relevant work experience in
- Prior medical device industry experience is required.
- Understanding of product and process change control, design
control, MRP / Inventory processes, and Quality System
- 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
- Ability to perform root cause analysis and recommendations for
- Understanding of product and process change control, MRP /
Inventory processes, and Quality System requirements. Preferred:
- Lean Champion and/or Six Sigma certifications preferred.
- Ability to use Mechanical CAD tools (Solidworks or ProE).
- Ability to read electronics schematics and mechanical
- Experience troubleshooting and documenting evaluations of
finished devices, sub-assemblies, and component failures. E dwards
is an Equal Opportunity/Affirmative Action employer including
protected Veterans and individuals with disabilities. Posted 2 Days
Ago Full time Req-7377 About Us 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 15,000 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.
Keywords: Edwards Lifesciences Gruppe, Irvine , Principal Electrical Manufacturing Engineer - Critical Care, Professions , Irvine, California
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