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Staff Mechanical Design Engineer - Test Method Development (THV)

Company: Edwards Lifesciences Corp
Location: Irvine
Posted on: April 5, 2021

Job Description:

This is a great opportunity for a Staff Engineer, Mechanical Design Engineering position within the Transcatheter Heart Valve (THV) new product development team. This role will be focusing on test method development and design characterization 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 Characterization and Design Verification testing. This Engineer will work in a fast paced and dynamic environment with multiple teams, where taking initiative and collaborating cross-functionally are critical for success. Key Responsibilities: * Manages all aspects of assigned test method development projects, collaborating with R&D, Quality, Manufacturing and other functions on test method development and inspection-related issues* Tracks projects and keeps projects to a timely schedule* Develops methods for R&D design characterization and Design Verification testing based off clinical use of finished delivery systems* Designs and creates new innovative inspection and measurement equipment that can be integrated within existing manufacturing processes* Develops automated inspection routines with measurement equipment and procures equipment appropriate for the method being developed* Develops inspections for supplier produced components which can be inspected either at the Supplier or at Edwards Receiving Inspection Facilities* Drafts, routes, reviews and approves inspection procedures and drawings* Leads innovation and development of novel automated inspection systems; seamlessly integrated into manufacturing processes* Performs statistical analysis such as capability, gage R&R, and statistical process control Education and Experience: * Bachelor's Degree in Engineering or Scientific field, with a minimum of 6 years of experience in R&D, Quality, or Manufacturing; OR Master's Degree in Engineering or Scientific field, with a minimum of 5 years experience in R&D, Quality, or Manufacturing. Required Qualifications: * Experience working within a highly regulated industry (i.e. medical device, pharma, automotive, or aerospace)* Demonstrated ability to influence, motivate, and accomplish results through peers and junior level engineers* Experience with complex Mechanical Design and Mechanical System Integration* Experience with 3-D printing for rapid design iteration* Proficiency with Solid Works for modeling, simulation, and design for machining* Experience with programing automated inspection vision systems* Proven ability to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel* Must be able to work effectively and collaborate within cross-functional teams* Proven ability to take initiative, work hands-on, multi-task, prioritize projects, maintain timelines, and communicate updates to management* Must be able to manage own projects and workload for self and lower level engineers and technicians Preferred Qualifications: * Technical Writing skills as applied to design documentation and method development - Experienced in the creation and revision of technical documentation* Experience with robotics, complex system design, and integration* Knowledge of Test Method Development best practices* Experience in performing test method validation and Gage R&Rs* Ability to travel up to 10% Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Keywords: Edwards Lifesciences Corp, Irvine , Staff Mechanical Design Engineer - Test Method Development (THV), Engineering , Irvine, California

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