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Principal Manufacturing Engineer, Process Development - Implant Network

Company: Jobleads
Location: Irvine
Posted on: May 3, 2021

Job Description:

We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. Principal Manufacturing Engineer, Process Development - Implant Network USA - California - Irvine The Principal Manufacturing Engineer, Process Development will lead the design, development, and implement advanced manufacturing processes for Edwards' Implant Network. In this role, the Principal Engineer will identify, develop, and validate state of the art process technology to achieve operational improvements for legacy processes and introduce advanced manufacturing technologies to assure new product success at launch. This role will apply principles of mechanical design, automation, chemical process design and facilities engineering while incorporating Six Sigma and Lean Manufacturing values to achieve organizational goals. The Principal Manufacturing Engineer will work closely with all Edwards implant manufacturing sites and across all business units to integrate and harmonize process equipment, processes, and associated infrastructure. This role will partner closely with R&D, Plant Operations leadership, Quality and Regulatory functions to develop strategies and tactics to launch and sustain technology capable to meet future business requirements. The Principal Manufacturing Engineer will be responsible to evaluate business cases for new technology concepts, develop complex manufacturing & equipment solutions, create execution strategies, manage project schedules & budgets and manage risk throughout the life of each project. This position will periodically report results to the Global Supply Chain Leadership Team and reports to the Senior Engineering Manager, Process Development. Essential job functions: Drive the design and development of highly complex process equipment (including writing and executing protocols) on a platform which includes multiple product lines to characterize, qualify and validate manufacturing processes. Conduct complex Design of Experiments, analyze results, make recommendations, develop reports and collaborate with team members to drive project completion. Initiate and lead the identification and business case analysis of opportunities to optimize/improve manufacturing processes using SIX Sigma & LEAN methodology and employing technical expertise and engineering skills to design products and processes for manufacturability. Employ project & risk management tools to timely completion and effective collaboration among cross functional team members and conduct stakeholder communication plans at all levels of the organization. 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. May be selected as an Independent Reviewer for design review. Perform other duties and responsibilities as assigned. Qualifications: Bachelor's Degree in Chemical, Mechanical or Materials Engineering or related scientific field with 8 years of process development manufacturing experience. Preferred Qualifications: Medical device industry experience highly preferred. Experience with key technologies and processes related to the assembly and manufacture of heart valves, surgical instruments, stents, catheters, delivery systems, and/or interventional devices is preferred. Demonstrated use of process and design excellence methodologies including Six Sigma. Design for Manufacturability and LEAN methodology. Effective knowledge of design transfer. Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills Expert in own area within the organization while applying broad-based technical expertise and has full knowledge of other related disciplines. Expert understanding of processes and equipment used in assigned work. Strong leadership skills and ability to influence change. Interacts with senior external representatives on significant technical matters often requiring coordination between parties. Proven expertise in usage of MS Office Suite. E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Full time Req-7936 About Us 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.

Keywords: Jobleads, Irvine , Principal Manufacturing Engineer, Process Development - Implant Network, Other , Irvine, California

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