Senior Manager, Lifecycle Management

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 139,000 - 196,000; Full time

Job summary

Edwards Lifesciences in California seeks a Senior Manager to lead global supply chain and process improvement initiatives for heart-related medical devices. You will coordinate with R&D, Quality, Regulatory, and Manufacturing to ensure uninterrupted supply and regulatory compliance.

Applicants should have a mechanical/manufacturing engineering degree with 10 years in medical devices, plus Lean Six Sigma and strong program leadership skills.

Qualifications

• Bachelor's Degree in engineering (Mechanical or Manufacturing) with 10 years in medical device manufacturing.
• Proven track record of commercializing and sustaining medical devices.
• Experience leading cross-functional teams.

Responsibilities

• Manage large-scale programs and enterprise-wide initiatives for global quality supply.
• Collaborate with R&D, Marketing, Quality, Regulatory, and Manufacturing to align objectives.
• Provide engineering expertise using Six Sigma/LEAN methodologies.
• Ensure Manufacturing Readiness Reviews before major builds after changes.
• Drive product launches into additional markets and suppliers.
• Quantify budget needs with Finance for project execution and resources.
• Escalate program risk when projects fail to deliver expected outcomes.

Skills

Cross-functional leadership

Project management

Problem-solving

Strategic thinking

Strong communication

Lean Six Sigma

Education

Bachelor's Degree in Mechanical or Manufacturing Engineering with 10 years experience

Tools

PLM

Ignite

GD&T

Automation design

Process validation

Microsoft Office

Job description

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs.The Senior Manager will lead the planning and execution of changes impacting Edwards' commercialized THV and/or TMTT product portfolios. Serving as a key cross-functional leader, this role partners with Manufacturing, Supply Chain, Quality, Regulatory, and Engineering teams to assess risks, drive alignment, and ensure successful implementation of initiatives such as supplier changes, new market launches, manufacturing transfers, and other post-commercialization product updates. This position plays a critical role in maintaining business continuity, regulatory compliance, and uninterrupted supply to patients and customers worldwide.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 distributionProvide 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 changesProvide 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.What you'll need (Required):Bachelor's Degree in engineering, preferably Mechanical or Manufacturing Engineering with 10 years of related experience providing technical engineering support in medical device manufacturing and a demonstrated track record of successfully commercializing and sustaining medical devicesExperience in Supply Chain such as Suppliers, Manufacturing, and/or DistributionExperience leading cross-functional teams without direct line reporting authorityWhat else we look for (Preferred):Lean Six Sigma Belt certificationTechnical 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. Understand principles, theories, and concepts relevant to Engineering.Expert knowledge of Design Control for Class II & III medical devicesExcellent problem-solving, analytical and critical thinking skillsProven 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.Extensive understanding of advanced processes and equipment used to manufacture medical devicesStrict attention to detailAbility to manage competing priorities in a fast-paced environmentAdhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/controlAligning 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.For California (CA), the base pay range for this position is $139,000 to $196,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.