Senior Manager, Lifecycle Management

Edwards Lifesciences•Irvine, CA

7d•$139,000 - $196,000

About The Position

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.

Requirements

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 devices
Experience in Supply Chain such as Suppliers, Manufacturing, and/or Distribution
Experience leading cross-functional teams without direct line reporting authority

Nice To Haves

Lean Six Sigma Belt certification
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.
Understand principles, theories, and concepts relevant to Engineering.
Expert knowledge of Design Control for Class II & III medical devices
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.
Extensive understanding of advanced processes and equipment used to manufacture medical devices
Strict attention to detail
Ability to manage competing priorities in a fast-paced environment
Adhere 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/control

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.