Edwards Lifesciences Principal NPD Manufacturing Engineer - GSC AT/TMTT in Irvine, California
This is an exciting opportunity to join the Global Supply Chain (GSC) – Irvine Advanced Technology/Transcatheter Mitral Tricuspid Therapies (TMTT) operation integration organization for TMTT products. The Principal Manufacturing Engineer will have high collaboration between R&D, Pilot and commercial manufacturing, contribute to from Early Human Use to commercialization of new product in the TMTT business unit, and the development of new or optimized manufacturing processes for TMTT in Heart Valve Center operations.
Essential job functions:
Utilize engineering methods (e.g. SIX Sigma, LEAN, etc.) to identify technical Gaps to establish Product and Process Capabilities, while employing technical design skills to re-design/design new products and/or processes. Ensure new products and processes are up to Edwards’ and industry standards, with a forward look toward compliance to ISO and other regulatory standards.
Serve as a subject matter expert in the area of process development for the broader Edwards organization with the ability to explain complex procedures and concepts in easy to understand terms in order to train and mentor peers and other employees.
Develop and execute complex experiments and tests (including writing and executing protocols) on a simple product line to qualify and validate manufacturing processes and/or equipment; analyze results, make recommendations, and develop reports
Work with R&D in the commercialization phase to execute the strategies for introducing new products and processes.
Analyze and resolve 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.
Perform other duties and responsibilities assigned.
- Bachelor's Degree in Engineering or Scientific field with minimum of 8 years of experience.
Medical device manufacturing experience in heart valves, stents, catheters, delivery systems and/or interventional access devices is preferred.
Lean Six Sigma certification is preferred.
Understanding of statistical technique.
Effective communication and project management skills.
Strong analytical, problem solving, and technical writing skills.
Ability to work well independently based on minimal guidance.
Strong interpersonal and intercultural skills.
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.