Senior Manager, Lifecycle Management

Edwards Lifesciences • Salt Lake, UT

9h • $139,000 - $196,000

About The Position

This position can be based either in Irvine, CA, Draper, UT, or Ireland. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Senior Manager will develop and ensure project management and deliver product design expertise to address new markets, continuous and quality improvements, regulatory changes, efficiencies across the Delivery Systems Network , production transfers, phase-out(s), synergies with the businesses, and unplanned events or disruptions while serving as core Leader with the THV business objectives to maintain a leading position through the plants in the delivery systems network. How you’ll make an impact: 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.

Requirements

• Bachelor’s degree in engineering or scientific, preferably Mechanical, or Manufacturing Engineering with 10 years of experience in providing technical engineering support in medical device manufacturing and a demonstrated track record successfully commercializing and sustaining medical devices.
• Experience in Supply Chain such as Suppliers, Manufacturing, and/or Distribution.
• Experience leading cross-functional teams without direct line reporting authority.
• Up to 15% domestic and international travel.

Nice To Haves

• Advanced degree.
• Technical knowledge and leadership in 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.
• Expert knowledge of Design Control for Class II & III medical devices, including familiarity with one or more of the following: delivery systems, automation, process engineering, packaging, labeling and distribution.
• Understand principles, theories, and concepts relevant to Engineering.
• Proven successful project management skills, including the development and management of dashboard.
• 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.
• Excellent documentation and communication skills.

Responsibilities

• 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.

Benefits

• Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior