Manager, Life Cycle Management - Implant Network
Company: Edwards Lifesciences Gruppe
Posted on: April 5, 2021
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Have you been searching for a role that brings you to the forefront
of innovation? We have an outstanding leadership opportunity join a
very collaborative team. The Manager Life Cycle Management (LCM)
will 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 with the business objectives to maintain a leading
position in the medical device market across surgical and
trans-catheter businesses. Essential job functions:
- 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
- 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.
- Perform other duties and responsibilities as assigned.
Education and Experience:
- Bachelor's Degree in in engineering, preferably Mechanical, or
- 10 years' experience in providing technical engineering support
in medical device manufacturing of and a demonstrated track record
successfully commercializing and sustaining medical devices.
- Experience leading cross-functional teams without direct line
reporting authority. Preferred Qualifications:
- Advanced degree is preferred.
- Experience in one or more areas of Supply Chain such as
Suppliers, Manufacturing, and/or Distribution and other functions
- 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.
- 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.
- Proven successful project management skills, including the
development and management of dashboard required.
- 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
- Extensive understanding of advanced processes and equipment
used to manufacture medical devices. E dwards is an Equal
Opportunity/Affirmative Action employer including protected
Veterans and individuals with disabilities. Posted 9 Days Ago Full
time Req-7220 About Us 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 15,000 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.
Keywords: Edwards Lifesciences Gruppe, Irvine , Manager, Life Cycle Management - Implant Network, Executive , Irvine, California
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