Edwards Lifesciences Manager, Life Cycle Management – Implant Network in Irvine, California
Have you been searching for a role that brings you to the forefront of innovation? We have an outstanding leadership opportunity join a very collaborative team. The Manager Life Cycle Management (LCM) will develop and ensure project management and deliver product design expertise to address new markets, continuous and quality improvements, regulatory changes, efficiencies across the Implant Network, production transfers, phase-out(s), synergies with the businesses, and unplanned events or disruptions while serving as core Leader with the business objectives to maintain a leading position in the medical device market across surgical and trans-catheter businesses.
Essential job functions:
Manage large scale to enterprise-wide programs and initiatives (e.g., Product Focus Team (PFT), process equipment and automation programs) for ongoing global continuity of quality supply for commercial products as well as upstream during the product development process. Ensure appropriate Global Supply Chain (GSC) integration into product lifecycle management through collaboration with R&D, Marketing, Quality, and Regulatory Affairs, and downstream with the manufacturing and other critical GSC functions to ensure alignment of objectives and activities. Provide engineering expertise including business excellence methods (e.g. Six Sigma and LEAN).
Provide solutions to manufacturing issues to ensure adequate business continuity and to guarantee the highest level of quality and service to customers to safeguard the medical product design (materials, tissues, delivery systems, and electro-mechanical devices) and manufacturing intent from suppliers through distribution.
Provide direction and guidance to project teams to execute tactical Supply Chain projects and/or initiatives; Ensure Manufacturing Readiness Reviews occur in advance of major builds following operations changes.
Provide analyses, and track progress against agreed upon key business and operating metrics. Provide input on executive summaries, and recommendations in support of new projects, initiatives, and/or programs to ensure adequate business continuity. Escalate program risk to management when (e.g., LCM, process equipment implementation) projects are not executed successfully or do not deliver anticipated outcomes.
Ensure successful integration of process technologies or transfer of stabilized products into and between Edwards Commercial Manufacturing facilities and External Manufacturers by working closely with the business partners from those areas. Continue to drive product launches into additional markets. Ensure risks and mitigations are known to stakeholders and Senior Leadership.
Partner with Finance to quantify budget need to support programs and initiatives including project resources, expenses and capital expenditures to support project execution.
Perform other duties and responsibilities as assigned.
Education and Experience:
Bachelor's Degree in in engineering, preferably Mechanical, or Manufacturing Engineering.
10 years’ experience in providing technical engineering support in medical device manufacturing of and a demonstrated track record successfully commercializing and sustaining medical devices.
Experience leading cross-functional teams without direct line reporting authority.
Advanced degree is preferred.
Experience in one or more areas of Supply Chain such as Suppliers, Manufacturing, and/or Distribution and other functions preferred.
Expert knowledge of Design Control for Class II & III medical devices, including familiarity with one or more of the following: device sterilization, implants, electro-mechanical devices.
Technical knowledge and leadership in the area of manufacturing engineering of medical devices including process excellence methodologies such as Six Sigma, cGMP, DFM, LEAN, EH&S guidelines, FDA guidelines ISO standards, ergonomics, GD&T, automation and equipment design and implementation, supplier development and process validation.
Proven successful project management skills, including the development and management of dashboard required.
Proven expertise in both Microsoft Office Suite and manufacturing systems (e.g. PLM, Ignite).
Excellent ability to translate highly complex and technical information to all levels of the organizations including executive leaders.
Extensive understanding of advanced processes and equipment used to manufacture medical devices.
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.