Senior Mechanical Design Engineer - Test Method Development (THV)

  • Edwards Lifesciences
  • Irvine, CA, USA
  • Jul 20, 2020
Full time Health Care

Job Description

This is a great opportunity for a Senior Engineer position on the Transcatheter Heart Valve (THV) new product development team. The Quality Engineer (QE) will be focusing on test method development for THV Delivery Systems.  In this role, it is expected that the Engineer works on developing test methods for use in Receiving Inspection, Manufacturing and for finished device design verification testing. The Engineer will work in a fast paced and dynamic environment with multiple teams.  Taking initiative and collaborating cross-functionally are critical for success.

Job Function:

  • Manages all aspects of assigned test method development projects
  • Tracks projects and keeps projects to a timely schedule
  • Drafts, routes, reviews and approves inspection procedures
  • Designs and creates new innovative inspection and measurement equipment that can be integrated within existing manufacturing processes
  • Develops inspections for supplier produced component which can be inspected either at the Supplier or at Edwards Receiving Inspection Facilities
  • Develops inspections for R&D and Design Verification testing based off clinical use of finished delivery systems.
  • Develops automated inspection routines with measurement equipment and procures equipment appropriate for the method being developed.
  • Provides support for conceptualizing gage and inspection fixture designs. Creates fixture designs as needed
  • Performs statistical analysis such as capability, Gage R&R, and statistical process control
  • Collaborates with R&D, Quality, Manufacturing and other functions on test method development and inspection-related issues

Required Qualifications: 

  • Bachelors' Degree in Engineering or Scientific field required with (4) four years of mechanical engineering, mechanical design, mechanical systems, quality, and/or manufacturing experience; OR Masters' Degree with (3) three years of the aforementioned experience
  • Experience and knowledge with Test Method Development and best practices
  • Proficiency with Solid Works, CREO, or similar tools for modeling, simulation, and design
  • Experience with 3D printing for design (or rapid design iteration)
  • Proficiency with design for machining
  • Programming and using automated vision or camera systems (i.e. Keyence, Cognex, Nikon)

Preferred Qualifications:

  • Medical Device industry experience
  • Experience with complex Mechanical Design and Mechanical Systems Integration
  • Experienced in performing test method validation and Gage R&Rs
  • Experience with programing automated inspection vision systems
  • Experience with Collaborative Robotics or integration of inspection methods into automated manufacturing methods
  • Experience with Electronics, Automation, pneumatics, and embedded PLCs
  • Proven expertise in usage of MS Office Suite
  • Working knowledge and understanding of statistical techniques
  • Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
  • Must be able to work effectively and collaborate within cross functional teams
  • Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel
  • Must have strong documentation skills
  • Must take initiative and have the ability to conduct hands-on work
  • Must possess the ability to handle multiple tasks with high attention to detail
  • Must be able to manage own projects and workload for self and lower level engineers and technicians
  • Ability to travel up to 10%

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.