This is an exciting opportunity for a Senior Engineer to manage and control the development and execution of assigned tooling programs and projects for the Critical Care organization. The Senior Engineer will coordinate & support R&D being an advisor to plastic parts designers. Supports in molder/mold-maker selection and mold design, builds, releases and validates phases on new tool projects. Support Operations personnel in developing/optimizing, documenting and implementing the supplier molding processes used in producing the products assigned. Assists suppliers in mold repairs as an advisor to tool room personnel and is responsible overseeing suppliers’ mold preventive maintenance and repair programs and systems.
Essential job functions:
Continuously assess organizational, equipment, operational and systemic needs to anticipate and resolve potential issues.
Keep in house a Mold History File/Database for each assigned mold, as well as a Mold Drawings History Record/Database.
Negotiate/design programs with suppliers that will ensure an adequate Preventive Maintenance and Spare Parts Program for each mold assigned.
Maintain a thorough knowledge of the assigned products, processes and their component parts from functional points of view.
Analyze plastic part quality problems as required and determine root cause traceable to mold conditions. Determine action plan and execute or support accordingly.
Coordinate with Supply Chain to obtain outside tooling contractors and vendors quotations.
Assist or coordinate the development of processes and molds/tooling necessary to produce new products.
Make recommendations regarding facilities, equipment, personnel, procedures, and systems, to assure conformance to (supplier or internal) quality standards.
New Product Development
Assist in the Design, development, or improvement of new or existing products or components.
Assist in planning, design, and development or test requirements and any special testing equipment to establish product specification.
Mold Construction, Repairs, Troubleshooting.
DFM & Product design for molding.
Plastics: materials / properties / design.
Molding: process capability / validations / troubleshooting.
Perform Failure Mode and Root Cause Analysis and Investigation.
Ability to travel (domestic and international) up to 25%.
Perform other duties and responsibilities as assigned.
Bachelor’s degree in engineering and scientific field.
Minimum 4 years’ experience in Molding/Mold-making/Tooling management/Injection molding in a manufacturing environment.
Must be able to work in a variety of environments (Laboratory, Office, Manufacturing Floor, Cleanroom, Molding Shops, Machine Shops and Tool Rooms).
Engineering degree in Mechanical Engineering or Plastics preferred.
Medical device industry desired.
Knowledge in Six Sigma desired.
Experience in Process Validations (IQ, OQ, PQ) and Test Method Validations (MSA).
Thorough understanding of Scientific Molding Principals.
Knowledge in Creo or SolidWorks.
Troubleshoot technical problems, determine and execute resolution plans.
Blueprint/Schematic reading and interpretation.
Understand tools and techniques to identify defects and causes.
Basic understanding of GMP/QSR/ISO-13485.
Proactive problem solver possessing technical leadership and communication skills that lead and transition new technologies from the laboratory to the manufacturing floor.
Internal Number: Req-6547
About Edwards Lifesciences
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.