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.

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

Preferred

• 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

Benefits

• 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.