Edwards Lifesciences Senior Mechanical Design Engineer - Test Method Development (THV) in Irvine, California
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.
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
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)
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.
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 13,000 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.