Edwards Lifesciences Staff Engineer – Plastics Part Designer in Irvine, California
The Staff Engineer for World Wide Engineering - Molding is a technical role supporting manufacturing sites by ensuring that injection molded parts used in commercial environment are robust, harmonized & scalable utilizing best practice in part design, development, technologies, process capable, validated per design control and compliant with Regulatory requirements. This role is responsible for plastic part design and development with involvement in injection mold tooling and injection molding processes including design for manufacturability, MoldFlow analysis and production release at suppliers. In addition, this role is part of a cross-functional team that is responsible for supporting sourcing strategies including supplier recommendation, evaluation and development. This position reports directly to the Senior Manager, Molding Engineering and resides in the Irvine location
Essential job functions:
Provide support to Engineering, Manufacturing and R&D in plastics engineering, injection mold design/construction and injection mold processing. Apply technical knowledge to innovate, design, develop processes, define requirements, establish procedures and implement tooling in support of thermoplastic injection molding and silicone liquid injection molding (LIM).
Lead Design for Manufacturability (DFM) input during product development phases including plastic part design and mold design & construction.
Support thermoplastic and silicone processing and tooling troubleshooting, and drive problem solving with suppliers.
Manage the implementation of new injection molds at suppliers. Drive process optimization and capability using scientific injection molding principles including process improvement opportunities and innovation on commercial products.
Project management from feasibility through implementation including charter & scope, detailed plan, defined schedule, risks mitigation, progress report and cost management. Escalate project risks to management, as required. In addition, plans, organizes, and conducts all aspects of technical reviews.
Supports IQ/OQ/PQ efforts within Edwards and at suppliers. Ensures proper documentation is completed to meet quality systems requirements. (e.g., Design Reviews, Component Drawings, FMEA’s, Manufacturing Procedures, BOM’s, Routers, etc.).
Ability to travel approximately 20%: domestic and international.
Perform other duties and responsibilities as assigned.
A Bachelor's degree in engineering.
Minimum of six (6) years of experience in providing technical engineering support in a regulated industry.
Demonstrated track record in executing large scale projects.
Advanced degree is desirable, preferably in Plastics.
Medical device manufacturing experience.
Technical knowledge and leadership in the area of plastics engineering, plastic part design, injection mold design & construction and injection molding process.
Strong expertise with ProE/Creo and SolidWorks solid modeling CAD and MoldFlow simulation software.
Phase gate product development expertise with plastic components including DFM expertise.
Hands-on experience in the area injection molding and injection mold construction.
Supplier relationship building, development and project support.
Problem-solving, analytical and critical thinking skills including high discretion/judgment in decision making.
Knowledge of technical manufacturing operations preferably in medical devices and process excellence methodologies such as Six Sigma, and FDA regulations, cGMP, ISO standards and EH&S guidelines.
Proven successful project management skills. Ability to manage competing priorities in a fast-paced environment.
Excellent documentation, communication and interpersonal skills. Ability to translate complex and technical information to all levels of the organization.
Innovative and strong execution skills with a demonstrated ability to deliver on short- and long-term strategic goals.
Proven expertise in IT platforms, preferably Microsoft Office Suite and manufacturing systems (e.g., PLM, Windchill, Ignite).
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.