Edwards Lifesciences Manufacturing Engineer II – GSC Pilot Operations in Irvine, California
Helping patients is our life’s work, and your contributions directly impact our ability to transform patient care around the world.” – Michael A. Mussallem, Chairman and CEO
The mission of Irvine Pilot Operations is to enable Edwards to achieve rapid product development cycles coupled with exceptional product reliability, efficient cost, and real-time product transfers through a strong partnership with the NPD teams and the global plant network.
The Manufacturing Engineer will support engineering and validation activities related to establishing equipment capabilities, equipment procurement, IQ/OQ, process development, as well as development of the Pilot Laser-cut processes and service center. This role will directly interact with other cross-functional engineering resources to support development and transfer of new processes and products to manufacturing.
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 moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.
Draft, approve, execute, and maintain relevant documentation such as SOPs, specifications, drawings, process sheets, FMEAs, and facilitate validation protocols (with an emphasis on software validation) as necessary to support implementation of equipment projects, as well as new process integrations.
Analyze and resolve moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
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.).
Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
Perform other duties and responsibilities as assigned.
Education and Experience:
- Bachelor's Degree in Engineering or Scientific field with 2 years of manufacturing engineering experience.
Advance degree is preferred.
Class II and Class III medical device manufacturing experience is preferred.
Lean Six Sigma certification is preferred.
Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering as well as the production development process (PDP).
Advanced problem-solving, organizational, analytical and critical thinking skills.
Effective communication and project management skills are required.
Strong analytical, problem solving, and technical writing skills.
Ability to work well independently based on minimal guidance.
Strong interpersonal and intercultural skills are 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 15,000 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.