Director, Lifecycle Management

Job Description:

The Director, Lifecycle Management 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 of Product Focus Teams (PFT) with the business objectives to maintain a leading position in the medical device market across surgical and trans-catheter businesses.

How You Will Make An Impact:
• Manage strategic 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), lead the facilitation of the overall project strategy and implement some changes as appropriate.
• Provide innovative solutions to complex manufacturing issues in specialized areas, internal or external, 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 larger Supply Chain projects and/or initiatives
• Prepare and lead the facilitation of the Supply Chain Readiness Reviews to align with the key project milestones
• Create a cross-functional environment and governance that fosters a rapid response for change control
• Ensure Manufacturing Readiness Reviews occur in advance of major builds following operations changes
• 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. Define and facilitate the synergies with the Business Unites (BUs) and the manufacturing sites.
• Establish, provide complex analyses, and track progress against agreed upon key business and operating metrics. Develop executive summaries, and recommendations to facilitate strategic decision making and gain buy-in from Senior Management 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.
• Partner with Finance to anticipate and quantify budget need to support programs and initiatives including project resources, expenses and capital expenditures to support project execution. Provide Operations input and assumptions into the financial business case with plan to maintain or improve profitability.
• Other incidental duties: Review and approval of Product Lifecycle Management file updates

What You’ll Need:

• Bachelor's degree in engineering, preferably Mechanical, or Manufacturing Engineering and 12 years of experience in providing technical engineering support in medical device manufacturing.

• Demonstrated track record successfully commercializing and sustaining medical devices throughout the end-to-end supply chain.

• Experience in multiple areas of Supply Chain such as Suppliers, Manufacturing, and/or Distribution and other functions preferred. Ability to set clear expectations and orchestrate all activities in those areas.

span of influence and control.

What Else We Look For:

• Master's degree in engineering, preferably Mechanical, or Manufacturing Engineering and 11 years of experience in providing technical engineering support in medical device manufacturing.

• Doctorate/PhD in engineering, preferably Mechanical, or Manufacturing Engineering and 8 years of experience in providing technical engineering support in medical device manufacturing.

• Strong 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, supplier development and process validation. Understand principles, theories, and concepts relevant