Edwards Lifesciences · 14 hours ago
Senior Manager, Lifecycle Management
Irvine, CA
Full-time
Onsite
Senior Level, Lead/Staff
$139K/yr - $196K/yr
10+ years expEdwards Lifesciences is a leader in medical device innovation, particularly in transcatheter aortic heart valve replacement. The Senior Manager will develop project management strategies and deliver product design expertise to enhance market presence and operational efficiencies within the Transcatheter Heart Valve business unit.
BiotechnologyHealth CareMedicalMedical Device
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
Qualification
Required
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
Preferred
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
Benefits
Competitive salaries
Performance-based incentives
Wide variety of benefits programs
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
10001+ employees
H1B Sponsorship
Edwards Lifesciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (81)
2024 (70)
2023 (42)
2022 (65)
2021 (44)
2020 (28)
Funding
Current Stage
Public CompanyTotal Funding
unknown2000-04-03IPO
Leadership Team
Bernard J. Zovighian
Chief Executive Officer
Andrew Greene
Vice President, Strategy
Recent News
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2026-01-20
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2026-01-14
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