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Engineer II, R&D/NPD - Transcatheter Heart Valve

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: February 23, 2021

Job Description:

We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. USA - California - Irvine 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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