Edwards Lifesciences Sr Manager, Ops Integration (LCM) in Irvine, California
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 of Product Focus Teams (PFT) with the business objectives to maintain a leading position in the medical device market across surgical and trans-catheter businesses.
• Manage strategic to enterprise-wide Product Focus Team (PFT) projects for ongoing global continuity of quality supply for both legacy and launched commercial products. 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 PFT project plan objectives and activities. Provide engineering expertise including business excellence methods (e.g. Six Sigma and LEAN),lead the facilitation of the overall project strategy and implement some changes as appropriate.
• Provide innovative solutions to complex manufacturing issues in specialized areas, internal or external, 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 larger Supply Chain projects and/or initiatives
• Prepare and lead the facilitation of the Supply Chain Readiness Reviews to align with the key project milestones
• Create a cross-functional environment and governance that fosters a rapid response for change control
• Ensure Manufacturing Readiness Reviews occur in advance of major builds following operations changes
• Ensure successful 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. Make sure risks and mitigations are known to stakeholders and Senior Leadership. Define and facilitate the synergies with the Business Unites (BUs) and the manufacturing sites.
• Establish, provide analyses, and track progress against agreed upon key business and operating metrics. Develop executive summaries, and recommendations to facilitate strategic decision making and gain buy-in from Senior Management in support of new projects, initiatives, and/or programs to ensure adequate business continuity. Escalation of program risk to management when LCM projects are not executed successfully or do not deliver anticipated outcomes.
• Partner with Finance to anticipate and quantify budget need to support LCM projects including project resources, expenses and capital expenditures to support project execution. Provide Operations input and assumptions into the financial business case for LCM projects with plan to maintain or improve gross profit targets.
• Other incidental duties: Review and approval of Product Lifecycle Management file updates
Bachelor's Degree in Engineering.
Twelve years of experience in providing technical engineering support in medical device manufacturing.
• 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
• Experience in multiple areas of Supply Chain such as Suppliers, Manufacturing, and/or Distribution and other functions preferred. Ability to set clear expectations and orchestrate all activities in those areas.
• Strong 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, supplier development and process validation. Understand principles, theories, and concepts relevant to Engineering.
• Strong leadership and influencing skills with the ability to build global strategic partnerships across the organization.
• Experience leading cross-functional teams without direct line reporting authority required
• Demonstrated skills in technical file updates
• Proven successful project management skills, including the development and management of dashboard required
• Ability to manage competing priorities in a fast-paced environment.
• Excellent problem-solving, analytical and critical thinking skills
• Proven expertise in both Microsoft Office Suite and manufacturing systems (e.g. PLM, Ignite)
• Excellent documentation and communication skills.
• Excellent ability to translate highly complex and technical information to all levels of the organizations including executive leaders.
• Expert understanding of advanced processes and equipment used to manufacture medical devices.
• Knowledge of financial budgeting and acumen to make financial and technical based recommendations to the business
• Strict attention to detail
• Ability to manage competing priorities in a fast-paced environment
• Ability to represent leadership on projects within multiple areas, interfacing with project managers,
• cross-functional teams and middle management
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.