Edwards Lifesciences Senior Manufacturing Engineer, GSC Pilot Implantables in Irvine, California
The Senior Manufacturing Engineering role is a great opportunity to support Edwards Lifesciences’ dynamic and rapidly growing Global Supply Chain (GSC) pilot manufacturing team. The vision of the organization is to enable Edwards to achieve rapid product development cycles coupled with exceptional product reliability, efficient cost, and real-time product transfer to the global plant network. As a Sr. Manufacturing Engineer, you will be providing engineering support during Design Verification & Clinical Builds by participating in the Material Review Board (MRB), lead and perform Non-conformance Report (NCR). Working closely with New Product Development (NPD) team, you will represent Pilot Manufacturing Engineering by providing input on manufacturing processes and Device Master Records creation. Lead and support Pilot initiatives to implement manufacturing best practices and production transfer as applicable.
Essential job functions:
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 of and ensure equipment, tools, fixtures, etc are up to standards.
Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes (IQ/OQ/PQ/SWV/TMV); analyze results, make recommendations, and develop reports.
Develop training and 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.).
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.
- Bachelors degree in engineering or scientific with 4 years of 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 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.