Engineer II, R&D/NPD - Transcatheter Heart Valve
Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: February 23, 2021
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Job Description:
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Edwards Lifesciences' Transcatheter Heart Valve Balloon Expandable
Delivery System NPD team is looking for an Engineer II to support
the development of our next-generation balloon expandable delivery
system. This Engineer II will have the opportunity to drive process
design and characterization, work on a strong cross-functional
team, and partner with the commercial site on process validations
and commercialization activities. This position provides experience
in the full development cycle from concept to
commercialization.
Responsibilities: Drive process development and characterization
for Early Human Use, Clinical, and Commercial device releases using
DMAIC methodologies Create user requirement specifications for
process equipment Collaborate on tooling and fixture design Develop
process validation strategies and participate in validation
execution in conjunction with the commercial manufacturing site
Drive process DFM, process FMEAs, and mistake proofing analysis and
implementation Collaborate on test method development Participate
in product design and specification development Participate in
product risk analysis Partner with Operations and Supply Chain at
the Pilot or Commercial manufacturing site for successful Clinical
and Commercial device releases
Required Qualifications: Bachelor's Degree in Engineering with 2
years of industry experience - OR - Master's Degree in Engineering
with internship, senior projects, or thesis in medical device
Strong verbal/written communication and interpersonal skills
Capable of analyzing and solving complex problems through
innovative thought and experience Ability to manage competing
priorities in a fast-paced environment Ability to work well
independently as well as part of a team Ability to interact
professionally with all organizational levelstrong problem-solving,
organizational, analytical and critical thinking skills Basic
understanding of statistical techniques Preferred Qualifications:
Previous experience in a manufacturing support role preferred
Process Validation experience strongly preferred Familiarity with
Design for Manufacturability and LEAN is preferred E dwards is an
Equal Opportunity/Affirmative Action employer including protected
Veterans and individuals with disabilities. Posted 16 Days Ago Full
time Req-6265 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 , Engineer II, R&D/NPD - Transcatheter Heart Valve, Engineering , Irvine, California
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