The R&D Engineer II will be responsible for participating in the root cause investigation of customer complaints for our Transcatheter Mitral and Tricuspid Therapies commercial devices and to develop and implement solutions as necessary to reduce complaint rates. The engineer will also support enhancements to commercial product based on customer feedback and R&D support of manufacturing improvements to increase quality and capacity. This is a newly created opportunity in a fast paced and rapidly growing organization.
Job responsibilities include:
Complete assigned complaints investigations, including but not limited to Product Failure Analysis and part/process updates.
Prepare information for complaint reviews, such as Quality Boards, CAPA updates, etc.
Author technical documents including protocols, reports, and technical summaries per quality and regulatory requirements
Manage DV activities and EQL submissions for changes to existing products
Facilitate with cross functional groups such as Quality, Manufacturing Engineering, and Production to ensure problem resolution by means of Root Cause/Problem Solving Analysis.
Lead implementation of corrective and preventive actions for design and manufacturing related issues.
Review customer feedback and support selected design enhancement to the commercial product.
Support manufacturing initiatives to improve quality and capacity through design impact assessments and performance testing as needed.
A bachelor's degree in engineering is required. Mechanical, Materials or Biomedical Engineering is preferred.
2 year or more experience in an engineering position is required.
Prior experience in the medical device industry is preferred as proficiency with key technologies and processes related to the assembly and manufacture of Class III cardiovascular devices and delivery systems will be critical to the success in this position.
Demonstrate strong project planning skills is required and experience with Design for Manufacturability is preferred.
Strong communication, project management, documentation and interpersonal skills is required.
Solid problem-solving, organizational, analytical and critical thinking skills.
Experience working in a dynamic team environment is preferred.
Edwards Lifesciences Corp