Edwards Lifesciences Engineer II, Lean Manufacturing – GSC Pilot Operations in Irvine, California
The Engineer II, Lean Manufacturing will support the Global Supply Chain (GSC) Pilot Manufacturing operations for the Irvine, CA location.
Primary responsibilities will include:
Technical expert for Manufacturing Execution System (MES) and LEAN within GSC Pilot Manufacturing Operations. Support long-term implementation of MES and Lean projects which drive operational excellence and final results.
Drive MES Modeler activities including but not limited to: model design and configuration, project management, model testing, sustaining line support and R&D updates.
Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills.
Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
Establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
Identify MES system integration issues with other projects/businesses and classify the improvements with the appropriate project/ business owners to accomplish the project goals.
Work seamlessly with cross functional team members within and across other business units.
10% travel to our Draper, UT manufacturing facility for MES training.
Perform other duties and responsibilities as assigned.
- Bachelor's Degree or equivalent in Engineering or a scientific field with 2 years of manufacturing engineering experience.
Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.
Basic understanding of statistical techniques.
Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering.
Solid problem-solving, organizational, analytical and critical thinking skills.
Solid understanding of processes and equipment used in assigned work.
Knowledge of applicable FDA regulations for medical device industry.
Strict attention to detail.
Ability to interact professionally with all organizational levels.
Ability to manage competing priorities in a fast paced environment.
Must be able to work in a team environment, including the ability to manage vendors and project stakeholders.
Ability to build productive internal/external working relationships that interface with, Quality, Engineering and other technical departments to achieve organization objectives.
Adhere to all EHS rules, regulations and risk assessments and take adequate control measures in preventing injuries to themselves and others as well as prevention of pollution to the environment.
10% domestic travel is required.
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.