Edwards Lifesciences Senior Manager, Strategic Automation Program Lead – Implant Network in Irvine, California
Have you been searching for a role that brings you to the forefront of innovation? We have an
outstanding leadership opportunity for you to join a global team implementing automation to our portfolio! We are looking for a Senior Manager to lead implementation of a Network-wide automation strategy critical to support future growth. The Senior Manager will understand, challenge, and adjust program strategy throughout implementation. Establish and maintain cross-functional alignment around project and program level direction. Align on and implement harmonized processes, equipment, and validations between our Implant Network which consist of three global manufacturing sites. Maintain cross-functional stakeholder alignment through formal and informal touch points including with executive leaders.
Essential job functions:
Lead strategic, automation program that leverages internally developed industry leading technology and deploy it across the manufacturing Network for multiple products. Leverage cross-functional partnerships to understand and anticipate the needs of multiple stakeholders to continuously refine the program strategy. Leverage SMEs to identify additional automation opportunities and lead prioritization and sequencing of technology implementation.
Build and maintain cross-functional partnerships across World-Wide Engineering, Manufacturing Plants, PMO, Business Excellence, Finance, R&D, Regulatory, Validation, Technical Training, Human Resources.
Guide development of a harmonized validation and regulatory strategy.
Partner cross-functionally to coordinate a global rollout of automation solutions. Ensure program is successfully completed within aligned upon schedule and resources.
Ensure harmonized equipment and processes are effectively implemented at each manufacturing site and solutions meet operational and business needs. Assess automation solution after implementation and adjust automation equipment design and implementation strategy accordingly.
Maintain stakeholder alignment through formal reviews and informal touchpoints. Stakeholders include individuals throughout the organization from line operators through executive leadership. Actively support change management effort to ensure successful adoption of new technology.
Partner with Finance to anticipate and quantify budget need to support automation program including project resources, expenses and capital expenditures to support project execution. Provide Operations input and assumptions into the financial business case as it evolves throughout implementation.
Perform other duties and responsibilities as assigned.
Bachelor's Degree in in engineering, preferably Mechanical, or Manufacturing Engineering.
12 years of experience in providing technical engineering support in medical device manufacturing and demonstrated track record successfully leading cross-functional project teams.
Experience in multiple areas of Supply Chain such as Suppliers, Manufacturing, and/or Distribution and other functions.
Dynamic and resourceful with ability to lead program with high strategic important and broad visibility.
Experience leading cross-functional teams without direct line reporting authority.
Strong Technical knowledge and leadership in the area of manufacturing engineering of medical devices including process excellence methodologies such as automation, DFM, LEAN, EH&S guidelines, FDA guidelines ISO standards, Six Sigma, cGMP, supplier development and process validation. Understand principles, theories, and concepts relevant to Engineering.
Proven ability to establish strong cross-functional partnerships.
Ability to think strategically and proactively identify and address stakeholder needs and program risks.
Proven successful project management skills to coordinate complex program of multiple projects.
Excellent problem-solving, analytical, and critical thinking skills.
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
Excellent ability to translate highly complex and technical information to all levels of the organizations including executive leaders.
Expert understanding of advanced processes and equipment used to manufacture medical devices.
Direct experience with automation or ability to quickly understand automation fundaments and how they support operational and business need.
Recognized as an expert in own sub-function(s) and/or area(s) within the organization with broad-based advanced knowledge within the organization.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.