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Supplier Development Engineer I - Critical Care

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: April 5, 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. Supplier Development Engineer I - Critical Care USA - California - Irvine The Supplier Development Engineer I will provide manufacturing engineering support in the design and development of novel Hemodynamic and Pressure Monitoring medical devices. This individual will conduct operations engineering activities at key suppliers from initial product development phase through commercial product launch. Among these activities are: applying Design for Manufacturability (DFM) concepts into component designs, collaborating with suppliers in the development of highly capable manufacturing processes to meet new product demands, performing process failure mode analysis, conducting supplier process validations and others related to design-transfer-to-manufacturing at suppliers. This is a dynamic, hands-on and supplier-focused role that will work in close partnership with R&D, Supplier Quality, Global Sourcing and Edwards Manufacturing Plants. Essential job functions include:

  • Working with multiple internal project teams to coordinate and execute supplier development deliverables at external electronic, plastic, cable, and sub-assembly component suppliers for Edwards Critical Care products.
  • Assisting suppliers to ensure that selection, development, and validation of manufacturing processes, equipment, and tooling are performed to the meet Edwards' procedures, ISO 13485 and FDA requirements.
  • Being the primary contact for designated suppliers and ensuring that all phases of product/process development conform to required quality standards while meeting program timing/key milestones for production launch.
  • Developing and writing technical reports/summaries, and validation/verification documents. Properly documenting activities in accordance with best engineering practices, company procedures, and regulatory requirements.
  • Resolving supplier component-related problems, including yield issues and failure analyses.
  • Providing ongoing quality monitoring and interface with external suppliers on manufacturing line issues to ensure highest quality product is maintained.
  • Training and educating suppliers on industry best practices and requirements to develop and improve their ability to meet medical device manufacturing industry expectations.
  • Facilitating and managing component level qualification testing that leads to the approval of components for use in Critical Care products.
  • Conducting supplier assessments to drive selection of robust suppliers and development plans for those suppliers needing performance improvement.
  • Supporting the generation and implementation of the Supplier Development department's quality system procedures.
  • Perform other duties and responsibilities as assigned. -- Requirements/Educations/Skills:
    • Bachelor's degree in engineering; mechanical, electrical or manufacturing engineering is preferred and 0-2 years of engineering experience in medical device manufacturing. An advanced degree may offset some required experience.
    • Basic understanding and with experience in performing medical device manufacturing process validations (IQ/OQ/PQ).
    • Basic Equipment knowledge and process experience for PCBA, SMT, injection molding, cable manufacturing, high volume product assembly, and environmental controls (clean rooms and water processing).
    • Good engineering judgement and demonstrated analytical, quality problem analysis, and resolution skills.
    • Strategic planning and critical thinking skills to be able to plan, organize, and manage multiple priorities.
    • Basic Ability to read and interpret engineering drawings for the purpose of understanding product design and identifying to critical to quality features.
    • Basic understanding of statistical techniques (Gage R&R, SPC, Process Capability Analysis, ANOVA, etc.).
    • Ability to work well both independently and as a member of a team is essential.
    • Excellent documentation and communication skills and interpersonal/intercultural relationship skills including negotiating and relationship management skills.
    • Knowledgeable in the use of Software: MS Office Package, Minitab (or equivalent statistical analysis software), SolidWorks.
    • Domestic and international travel is required. Expected 25% travel. E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Full time Req-7055 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 , Supplier Development Engineer I - Critical Care, Engineering , Irvine, California

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