Staff Engineer, Supplier Engineering - Transcatheter Mitral Tricuspid Therapy
Company: Edwards Lifesciences
Location: Irvine
Posted on: January 13, 2021
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Job Description:
The opportunity will reside in the Transcatheter Mitral
Tricuspid Therapy (TMTT) Supplier Engineering team to provide
manufacturing engineering support in the design and development of
implantable devices and delivery systems to treat cardiovascular
disease. Conduct engineering activities from initial product
development phase through product launch. Develop manufacturing
technologies to meet new product demands. Apply Design for
Manufacturability (DFM) concepts, tools and analysis. Conduct
reviews to ensure DFM considerations are incorporated into designs.
Assess and develop supplier part capability. Work directly with
suppliers to address specifications and quality requirements. Lead
supplier validation activities, support initial builds and
commercialization of new product introduction. Integrate new
products into manufacturing. Manage product phase in/phase out
activities around design, regulatory and clinical requirements.
Support manufacturing readiness reviews and manage components and
subassembly design transfers to manufacturing.Essential job
functions include:Coordinates tooling / process capability studies
as required.Responsible for new injection molding and/or metal
components providing end-to-end qualification, from design input
through mold validation. This includes part design, process
development on new tools, material change and process
improvements.Provides technical input for strategic sourcing
projects, including evaluation of supplier capability, part
qualification plan, specification review, product implementation
and part transition to manufacturing.Participate in technical
discussions with suppliers to identify and implement improvements
in products and processes.Responsible for defining supplier
qualification requirements for OEM, Contract manufacturer
(components and devices) and custom materials, including supplier
validations and Edwards receiving inspection fixture design for
Test method validation. Respond with a high sense of urgency to
quality issues and escalate / communicate appropriately.Ensure that
Tier 1 suppliers are using capable Tier 2 suppliers for material
and outside processing services.Work with supplier to optimize
processes.Travel up to 20%.Perform other duties and
responsibilities as assigned.Qualifications:Bachelor---s degree in
engineering with 6 years of manufacturing engineering
experience.On-site work
required.Requirements/Educations/Skills:Master---s degree in
Mechanical or Biomedical is preferred.Medical device manufacturing
experience in heart valves, stents, catheters, delivery systems
and/or interventional access devices is preferred.Understanding of
statistical techniques.CAD experience using ProE
preferred.Effective communication skills areAbility to work well
both independently and as a member of a team is essential.Strong
analytical, problem solving, and technical writing skills are
required.Edwards is an Equal Opportunity/Affirmative Action
employer including protected Veterans and individuals with
disabilities. Full time
Keywords: Edwards Lifesciences, Irvine , Staff Engineer, Supplier Engineering - Transcatheter Mitral Tricuspid Therapy, Other , Irvine, California
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