Edwards Lifesciences Senior Manufacturing Engineering-Pilot Advanced Catheter in Irvine, California
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 Senior Manufacturing Engineer will support engineering and validation activities related to establishing equipment capabilities, equipment procurement, IQ/OQ, process development, initial stabilization of new and in-sourced steerable catheter shafts for early human use as well as support of transfer activities. Additional objectives may include setting and optimizing cleanroom configuration and layouts to improve quality and performance. This role will directly interact with the Advanced Catheter COE and other cross-functional engineering resources to support development and transfer of new processes and technologies to manufacturing.
Essential job functions:
Develop 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 as necessary to support implementation of equipment projects, as well as new process integrations.
Develop training and JDOC documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods), employing technical design skills to re-design/design and ensure equipment, tools and fixtures are up to standards.
Guide manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations) as applicable.
Perform other duties and responsibilities as assigned.
Bachelor's Degree in Engineering or Scientific field.
Minimum of 4 years’ experience in manufacturing engineering.
Medical device manufacturing experience in steerable catheters, nitinol stents and/or braiding, catheters, delivery systems and/or interventional access devices is preferred.
Advanced degree or Six Sigma certification is preferred.
Familiarity with Design for Manufacturability and LEAN is preferred.
Proven expertise in usage of MS Office Suite including MS Project; MES and/or CAD experience preferred.
Strong verbal/written communication and interpersonal skills.
Strong project management skills.
Basic understanding of statistical techniques.
Previous experience in a manufacturing support role preferred.
Strong problem-solving, organizational, analytical and critical thinking skills.
Process Validation experience.
Capable of analyzing and solving complex problems through innovative thought and experience.
Ability to manage competing priorities in a fast-paced environment.
Ability to work well independently as well as part of a team.
Good leadership skills and ability to influence change.
Ability to interact professionally with all organizational levels.
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.