Director, New Product Introduction - Structural Surgical Heart Request ID: Req-23438 Location: [...]
Company: Edwards Lifesciences
Posted on: March 15, 2023
The Director of New Product Introduction will be responsible for
leading Global Supply Chain activities from concept development
through commercialization, required for the readiness and
successful launch of new products to the market. Serve as a core
team member on new product development teams ensuring alignment
across functions and all regional and global supply chain
stakeholders.Essential job functions:
- Development and execution of a Supply Chain Plan for assigned
new product development / introduction (NPD/I) projects. Ensure
appropriate Global Supply Chain (GSC) integration into the NPD/I
process through early collaboration with NPD Team Leader, R&D
and Marketing. Build relationships with business partners to ensure
the alignment of Supply Chain Plan objectives and activities.
Provide technical expertise and lead the facilitation of portions
of the supply chain strategy.
- Provide direction and guidance to project teams to execute
tactical supply chain projects and/or initiatives
- Prepare and lead the facilitation of the Supply Chain Readiness
Reviews aligned with project phase gates.
- Ensure Manufacturing Readiness Reviews occur in advance of
- Update all relevant project information in tracking tools such
- Establish, provide analysis and track progress against agreed
upon key business and operating metrics related new product
launches and commercialized products as assigned.
- Manage large scale to enterprise-wide product launch projects
including partnering with cross-functional teams (e.g., Planning,
Sourcing, Distribution, Logistics, Engineering, Pilot and
Commercial Manufacturing), on the integration of New Products into
manufacturing with a future look towards lifecycle management,
sustaining activities and other Operations responsibilities.
- Develop the Global Supply Chain (GSC) project resource plan
including people, expense and capital expenditures to support
project execution. Provide Operations input into the financial
business case for a new product with shared responsibility for new
product cost of goods sold and plan to meet gross profit
- Ensure successful transfer of new products into External
Manufacturers, Pilot and Commercial Manufacturing facilities by
working closely with business partners from those areas. Continue
to drive product launches into additional markets. Make sure risks
and mitigations are known to stakeholders and senior
- Manage and oversee the work of a team with responsibilities for
multiple NPD/I projects including ownership of project milestones,
risks and mitigations. Develop a robust talent development plan in
alignment with functional growth strategies of the department
including coaching, mentoring, and knowledge transfer.
- Review and approval for assigned product development process
- Perform other duties and responsibilities as
- Bachelor's Degree in engineering or scientific discipline.
- Minimum of 12 years of manufacturing operations experience with
five of those years in the development and/or introduction of new
products into supply chain a regulated industry.
- Minimum of five years of leading cross functional teams.
Experience leading cross functional teams without direct line
- Strong collaborator and communicator with a high degree of
emotional intelligence and the ability to understand business
partner needs and manage satisfaction relative to
- Technical understanding of manufacturing engineering, design
for manufacturability, design and process excellence methodologies
including Six Sigma, LEAN experience, cGMP, EH&S guidelines,
supplier development and process validation.
- Experience in multiples areas of Supply Chain such as Sourcing,
Manufacturing, Planning and/or Distribution.
- Knowledge of design controls for Class II & III medical
devices, including familiarity with one or more of the following:
device sterilization, implantable NiTi, CoCr & tissue,
electro-mechanical devices, and catheter-based delivery
- Understanding of critical to quality (CTQ) design elements and
cascading CTQs to design inputs / outputs and establishing process
controls / limits.
- Advanced project management skills and ability to explain
complex concepts and strategies in understandable terms.
- Experience in preparing for and presenting project status to
executive leadership, including the development, and managing of
- Ability to set clear expectations and orchestrate all
Operations activities related to Planning Sourcing, Manufacturing,
Distribution and other functions.
- 15% travel.Preferred Qualifications:
- Advanced degree or MBA preferred.
- Certification in related discipline preferred (e.g., CPIM
Certification or Project Management Certified, Green Belt
- Experience within the medical device industry.
- Strong business and financial acumen. Ability to develop and
manage project budgets, understanding of business case development
including net present value and internal rate of return on capital
investments.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.For
California, the base pay range for this position is $141,000 to
$200,000 (highly experienced).The pay for the successful candidate
will depend on various factors (e.g., qualifications, education,
Keywords: Edwards Lifesciences, Irvine , Director, New Product Introduction - Structural Surgical Heart Request ID: Req-23438 Location: [...], Executive , Irvine, California
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