Junior Quality Design Engineering

Innovation starts from the heart.

At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease and critical care.

As part of our Quality Designer Engineering team, you will work closely with our R&D, Quality, Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world.

The Edwards Israel Innovation Center (EIIC) focuses on developing early-stage cardiovascular technologies.

Our passion, ingenuity, collaboration, and new ways of thinking enable us to develop devices and therapies that help patients around the world.

How you will make an impact:

• Transforms engineering specifications to finished CAD Designs for manufacturing and products, e.g., tooling /fixtures, detailed assembly drawings, and part drawings.
• Advises engineering on geometric dimension and tolerance, critical dimensions of the design, and alerts the engineers to potential issues regarding the fabrication process.
• Ensure appropriate and necessary documentation is in place to meet EW Quality System in compliance with regulatory requirements
• Identify, lead and implement business process improvement solutions for Quality systems, including developing changes to procedures, to improve operation, efficiencies, and user experience, while supporting the integrity of the business process
• Improve and implement quality systems processes, including applications, documentation and training.
• Recommend changes to documentation associated with Quality Systems, as well as assessing effectiveness and approving recommendations of others.
• Process Engineering Change Requests (ECR) including describing changes and providing corresponding technical justification; checking completed layouts and drawings for clarity, completeness, conformity to standards, procedures, specifications; and accuracy of calculations and dimensioning and notes necessary to present design proposals.
• Design basic fixtures or products, incorporating ease of manufacturing, safety, performance, and reliability; and selecting equipment and materials. Identify design errors, omissions, and other deficiencies, including redline reviews
• Create new designs utilizing parametric solid modeling software or applications to develop basic data, assemblies and detailed parts of devices, mechanisms, and structures.
• Evaluate changes proposed by initiators and provide feedback and recommendations for improvement and compliance
• Assist in implementing new processes and methods in collaboration with Engineering and Quality
• Review change package against governing procedures interact with departments to complete the change package, incorporate approved changes to documentation and release final change package.
• Assist in creating presentations for internal and external functions to secure consensus on the design viability and functionality.
• Coordinate and perform incorporation of approved changes to documentation (e.g. JDE data entry and verify correct implementation)
• Initiate ECR's
• Other duties as assigned by leadership
  
  

• Bachelor's Degree Graduate in related field (Biomedical Engineering/ Mechanical Engineering/equivalent)
• 0-2 years of related experience
• Strict attention to detail
• Fluent English
• Excellent written and verbal communication skills
• Problem solving methodology, tolerance analysis, and GDP (Good Documentation Practices)
• Expertise in usage of CAD (e.g Creo, Solidworks, AutoCAD, CAD PDM) and MS Office Suite
• Experience in reading, interpreting, and creating drawings
• Must be able to work in a team environment, including immediate supervisor and other team members
  
  

• Basic understanding of CAD design principles, techniques and procedures including parametric solid models
• Moderate understanding of ASME Y14.5M-1994 drawing standards
• Moderate ability to utilize 2-D and 3-D CAD software
• Basic understanding of fabrication processes (e.g machining, molding) to leverage in creating and evaluating designs
• Basic understanding of materials and materials properties
• Basic understanding of DFM (Design for Manufacturing) concepts and principles